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Regulatory Affairs Intern Jobs in Plymouth, Iowa

Regulatory Affairs Intelligence Specialist
By Abbott Laboratories At , Plymouth $56,700 - $113,300 a year
Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
Experience in program management a plus
Experience with document management systems a plus
EDUCATION AND EXPERIENCE YOU’LL BRING
Performs other related duties and responsibilities, on occasion, as assigned
Strong verbal and written communication skills · Strong attention to detail and organizational skills
Regulatory Affairs Strategist Jobs
By Navitas Life Sciences At , Remote
Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines
Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders
Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
There is a travel requirement of up to 10%
Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market
Sr. Regulatory Affairs Specialist
By Abbott Laboratories At , Des Plaines $71,300 - $142,700 a year
Interpret and apply regulatory requirements
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
Principles and requirements of promotion, advertising and labeling
Has broad knowledge of various technical alternatives and their potential impact on the business
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Regulatory Affairs Specialist Jobs
By Philips At , Cambridge
Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
Proficient knowledge of domestic and international standards
Experience in supporting international registrations and/or clinical investigations.
Experience with Software Medical Devices strongly preferred.
Proficient computer skills in Microsoft Office Suite
Read more about our employee benefits.
Associate Iii, Regulatory Affairs
By Sandoz At , Princeton $97,600 - $146,400 a year
Effectively monitor and track information and requirement changes
Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.
Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals
Excellent oral and written communication skills
Pharmaceutical or generic drug experience in a regulatory capacity
Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)
Regulatory Affairs Professional Jobs
By Sartorius At , Remote
Deep knowledge of the relevant Regulatory requirements
Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths
8+ years relevant experience within the Regulatory Affairs discipline
Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.
Proven analytical skill and technical/scientific competence.
Strong initiation and organizational skills
Senior Regulatory Affairs Associate, Fsp
By Parexel At , Remote
Management Strong management with depth of experience working for global health authorities.
Experience with project lifecycle and management
Strong management with depth of experience working for global health authorities.
Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support.
Interacts professionally at multiple levels including senior management within a client organization.
Successfully penetrates executive management levels or other business units within a client organization.
Intern, Global Regulatory Operations
By Viatris At , Remote $20 an hour
Provide support for data research/verification, system training support, data entry, and system testing
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Regulatory Affairs Specialist - Remote
By Corza Medical At , Remote
Superior Quality & Service. We deliver extraordinary experiences.
Development of tracking documents and follow-up to assure submissions are managed appropriately.
Minimum 2 years of experience in Regulatory Affairs in the medical device/drug industry.
Experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America.
Experience with medical device regulations (21 CFR, MDR, MDSAP, ISO 13485) and Biologics License Applications (21 CFR) preferred.
We do what is right.
Regulatory Affairs Specialist Jobs
By GC America Inc At , Remote
Consult with Product Management and Sales Administration on regulatory requirements for US and Canada
Work with product management to prepare, compile and maintain post market documentation
3 years of experience in regulatory affairs or quality assurance
Monitor regulatory environment in assigned markets(US, Canada) and communicate to global and domestic stakeholders
Prepare responses to regulatory authority requests by working with GCC regulatory affairs
Work with other GC Companies regulatory associates to support GCA sales and marketing needs associated with regulatory documentation
Vice President, Regulatory Affairs (West)
By Invenergy At , Remote $200,000 - $240,000 a year
Collaborate with internal business partners in development, asset management, legal, transmission, interconnection and origination functions
Preferably a BS in Business, Economics, Finance, or Engineering or commensurate job experience. MBA or law degree preferred.
Collaborate with the other Regulatory Affairs team members in other regions and manage direct reports as appropriate
Manage external counsel and consultants
Knowledge of organized power markets. Knowledge of CAISO and ERCOT highly preferred.
Knowledge of FERC and NERC standards related to transmission and interconnections, including Open Access Transmission Tariff (OATT) preferred.
Assoc. Director / Director, Global Regulatory Affairs
By AVROBIO At , Remote
Experience interacting with the FDA and ex-US health authorities and current knowledge of global regulations, and guidance’s/guidelines
Experience in the development and preparation of successful regulatory strategies
Cell and gene therapy and/or rare disease experience preferred
Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines
Develop and implement global regulatory strategies including timings for regulatory interactions, pediatric development, orphan drug designations and routes to approval
Highlight and mitigate potential risks to timelines and deliverables
Specialist Data Maintenance Regulatory Affairs
By Viatris At , Remote $41,000 - $93,000 a year
Builds knowledge of electronic and paper publishing systems and tools and applies these tools to produce CMC change management outputs.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Regulatory Affairs Associate Jobs
By BeiGene At , Remote $33.99 - $46.01 an hour
Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable
Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents
Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (nonclinical, clinical)
Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations
Project Management - Communicates changes and progress; Completes projects on time and budget.
With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical and non-clinical
Intern, Medical Affairs Jobs
By Axogen At , Tampa, 33602, Fl $18 an hour
Comprehensive, high-quality benefits package effective on date of hire
Educational assistance available for all employees
Experience with Teams, SharePoint, and prefsocial media content creation preferred
Requirements of the Medical Affairs Internship
Friendly, open, and fun team culture that values unique perspectives
Company-wide dedication to profoundly impacting patients' lives
Director Of Regulatory Affairs
By Trebla Talent At Greater Chicago Area, United States
Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma
Both clinical and CMC experience is desired
Bachelor’s degree is required; advanced degree is preferred.
A passion for the psychedelic and mental health industry
Director/Senior Director of Regulatory Affairs
Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
Remote: Vice President Regulatory Affairs
By Shepherd Regulatory Search At United States
At least 15 years of Global Regulatory Affairs leadership experience.
Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.
Provide global regulatory leadership supporting global development.
Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.
Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.
California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Regulatory Affairs Associate Jobs
By Agilent Technologies At California, United States
Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
Maintain and updates information about global regulatory requirements.
4+ years of Regulatory Affairs experience
Post-graduate and/or certification/ license may be required.
Review product labeling and marketing materials for accuracy and compliance with regulations.
Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
Regulatory Affairs Consultant (Freelance)
By Alien Technology Transfer At United States
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

Vp Quality And Regulatory Affairs
By Proven Recruiting At San Diego, CA, United States
Management review of quality and regulatory team.
Manage the preparation and development of regulatory submission packages.
Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
Prior experience authoring and filing of regulatory documents.
Responsible for regulatory submission strategies to support product development and approval of various medical device products.
Interface with regulatory authorities and internal technical teams on regulatory submissions.
Vice President Regulatory Affairs
By Albion Rye Associates At United States
Offer strategic regulatory counsel to senior management.
Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities.
You must have at least 15 years of managerial experience in the medical devices sector.
Head a skilled, diverse regulatory affairs team adept at navigating global regulations.
Devise and execute strategies for prompt global product launch while adhering to regulations.
Assure comprehensive and lawful post-launch product backing.
Regulatory Affairs Lead Jobs
By Bramwith Consulting At United States
Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)
Experience working within US regulatory affairs within the pharmaceutical or healthcare industry
Experience of regulatory submissions and approvals, including new BLAs/NDAs
Experience with licensing including negotiating directly with the FDA
Salary - $150,000 to $160,000 plus excellent bonus and benefits
across their entire business. As part of this growth, the business is looking to hire an experienced
Regulatory Affairs Lead Jobs
By Bramwith Consulting At Massachusetts, United States
Ensure sustained quality and efficiency through modern artwork management systems
Extensive experience working with Healthcare/Pharmaceutical product labelling
Consistently drive continuous improvement related to global Pharmaceutical labelling
Work highly cross-functionally with wider global teams, and educate global stakeholders of labelling best practices
Strong understanding of Pharmaceutical Regulatory Bodies across a global remit
Degree from a leading college
Regulatory Affairs Analyst Jobs
By San Jose Water At San Jose, CA, United States
Required Knowledge Skills & Abilities
· Working knowledge of statistics, investments, budgeting, project management and computerized applications.
· The Regulatory Affairs Analyst requires substantial technical skill in finance, economics, and statistics.
· Utility rate-making methodologies and legal requirements.
· Excellent written and oral communication skills.
· A bachelor's degree or equivalent in finance, economics, accounting, engineering or a closely related field.
Regulatory Affairs, Noram Jobs
By Biocon Biologics At New Jersey, United States
Minimum 12 years relevant experience out of which more than 5 years of people manager role
Responsible for Noram regulatory strategy of both products approved and products under development.
Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative
Supports development of Noram regulatory policy priorities, generates policy positions, develops action plans.
Responsible to prepare, review and approval of module 1 sections in partnering with GRL and make them available for NDS submission
Assist North America head on product development strategy and participate in building the regulatory strategy.
Regulatory Affairs Consultant - Usa Remote
By Alien Technology Transfer At ,
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Regulatory Affairs Specialist Jobs
By ICON At , Farmingdale, 11735
Experience in regulatory requirements in clinical phase of biologics drug development is a plus
Excellent written and oral communication skills
Strong technical writing and editing skills
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
Initiate regulatory submission when required and support ICON team with Regulatory Inspections
Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
Regulatory Affairs Associate Jobs
By Earth Animal At Southport, CT, United States
Identify claims issues and lead/offer alternatives to comply with regulatory guidelines while supporting business needs.
Must be a solution oriented, self-starter with demonstrated problem solving skills.
Skilled in Excel and demonstrate accuracy with collecting and analyzing data.
Responsibilities include but are not limited to:
Lead regulatory functions and collaborate with cross-functional partners in support of the marketing review and documentation proofing process.
Regulatory Claim Subject Matter Expert (Marketing Support and Review)
Regulatory Affairs Associate Jobs
By Aditi Consulting At Plainsboro, NJ, United States
Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.
Reports to labeling management in Regulatory Operations and Innovation.
Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).
May be responsible for managing projects, processes, or programs with manager oversight.
Experience and/or Familiarity with Structured Content is preferred
Excellent verbal and written communication and skills.
Medical Affairs Intern Jobs
By Maimonides Medical Center At , Brooklyn, 11219 $15 an hour
Assist business intelligence and value-based management team in developing projects utilizing external and internal databases.
Assist value-based management team in engaging stakeholder on project objectives, processes deliverables, analysis, goals and success measures, while managing expectations.
Strong interest in Project Management
Plans, manages and coordinates project activities.
Strong verbal and written communication skills
Strong analytical and problem-solving skills
Specialist, Regulatory Affairs Jobs
By Edwards Lifesciences At ,
Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge of new product development systems
Ability to manage competing priorities in a fast paced environment