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Regulatory Affairs Internship Jobs

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 ...

Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc. At Austin, TX, United States
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
The job description is detailed below:
Duration: 1+ year with possibility of extension
5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances
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 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
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 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
Global Clinical & Regulatory Affairs Operations Coordinator
By Orion At , $28 an hour
Experience with vendor and supplier management and engagement
Experience with contract management systems for legal agreements and contracts
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Bachelor's Degree in Business Administration, Economics, or related field preferred or a combination of education and experience.
Experience working in a fast-paced remote environment preferred as well as experience working with highly matrixed global organizations
A minimum of 3 years' experience in clinical regulatory affairs highly preferred.
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)