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Regulatory Affairs Jobs in Morris, New Jersey

International Regulatory Affairs Specialist
By Scholl's Wellness Company At Parsippany, NJ, United States

Seeking a part time International regulatory consultant to help manage International product registrations in select International markets Must be familiar with the International registration process ...

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 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.
Regulatory Affairs Manager Jobs
By Keystone Industries At Gibbstown, NJ, United States
Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and Quality Management Systems (QMS).
Collaborate with QA to ensure the quality management system (QMS) complies with relevant regulations and standards.
Oversees the implementation of risk management processes. Work with cross-functional teams to identify and address potential risks associated with regulated products.
Assesses the impact of regulatory changes on the company's products and processes and ensures compliance with these requirements.
Advise project teams on premarket regulatory requirements.
Advise on export and labeling requirements.
Regulatory Affairs Cmc Scientist 1/Manager
By Daiichi Sankyo, Inc. At Basking Ridge, NJ, United States
5-8 years pharmaceutical industry experience with 2+ years direct or related CMC regulatory experience
Basic knowledge of regulations/guidance documents and pharmaceutical development process.
Strong oral and writing skills. Able to compile early/simple submission under supervision.
B.S. in a scientific discipline, graduate degree in a scientific discipline preferred
Join a Legacy of Innovation 110 Years and Counting!
Regulatory Affairs Associate (Remote)
By Gardner Resources Consulting, LLC At Princeton, NJ, United States
• Experience with submission work in VaultRim
• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER annual reports)
Qualified applicants will have the following expertise:
Regulatory Affairs Specialist; Labeling
By NewAgeSys, Inc At Princeton, NJ, United States
Creating and Maintaining SPLs for products in alignment with changing technical requirements.
Education: Bachelor's or Associate’s degree in a scientific discipline or English.
Req Title: Regulatory Affairs Specialist; Labeling
Client: A major pharma company
Work Address: 100 College Road West, 08540, Princeton, NJ
Supporting and prioritizing launch labeling components readiness for a successful launch.
Regulatory Affairs Specialist Jobs
By Reqroute, Inc At New Jersey, United States
•Effective time management and organizational skills
•Team management and team engagement
•Taking care of administrative responsibilities of team
Qualifications we seek in you!
•In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission, and industry-standard publishing systems.
•Proven rich experience in Pharmacy Regulatory Affairs
Reviewer, Regulatory Affairs Advertising & Promotion
By Tris Pharma Inc At , Monmouth Junction, 08852, Nj
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Knowledge of pharmaceutical/biotechnology industry (i.e., Medical/Clinical Affairs, Regulatory Affairs, Commercial, Product Development, etc.) acquired through industry and/or academic experience
Minimum education and years of relevant work experience
Special knowledge or skills needed and/or licenses or certificates
Excellent verbal and written communication and skills
Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Program Assistant (Regulatory Affairs)
By Rutgers University At New Brunswick, NJ, United States
Equivalent education, experience, and/or training may be substituted for the degree.
Bachelor’s Degree plus one (1) year related experience.
Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel,Access, and PowerPoint.
Demonstrated effective oral and communication skills.
Bachelor’s Degree plus one (1) year related experience in a clinical research regulatory capacity.
Prepares and submits all necessary documents to the Institutional Review Board. Ensures regulatory approvals are obtained.
Specialist, Regulatory Affairs Jobs
By CHANEL At Piscataway, NJ, United States
Section 5: What skills you will learn? What experiences might you have?
Trained and acting in-person coverage for quality assurance (QA) personnel, as well as helping manage QA union inspectors when needed
Minimum Education: B.S. Chemistry or related science
Minimum Years of Experience: 1-3 years of Cosmetic or related industry experience
Special Requirements of the Position: French speaking a plus
Communication skills (both internal and external)
Regulatory Affairs Manager Jobs
By Talencio At Greater Minneapolis-St. Paul Area, United States
Provides leadership and supervision to the IRB & Regulatory Specialists, including coaching, performance management and staff development.
Cardiovascular research experience or general knowledge of common cardiovascular medical terminology
Experience developing and delivering educational content
Delivers routine educational and training content to research staff on an as-needed basis.
Other opportunities for significant, high-level contribution may be available dependent upon candidate interest and experience and program need.
5 years of experience in research with a deep understanding of the clinical research and IRB oversight processes
Vice President Of Quality And Regulatory Affairs
By Staffing Resource Group, Inc At Cranbury, NJ, United States
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
Project Management, Change Execution Management and Team Leadership experience in a Quality function a plus.
·Management of QA, QC, and Compliance team
·Demonstrated supervisory experience, leadership, and teamwork skills.
Ability to work independently as well as manage teams.
Strong quality mind and technical knowledge.
Director Of Regulatory Affairs
By Metric Search At Marlton, NJ, United States
Ensure that domestic and international regulatory filings assigned meet regulatory requirements.
Create project plan, manage timelines and priorities on all submissions
Manage technical file documentation for international approvals in multiple geographies.
Working knowledge of standards and regulations as outlined in the QMS documentation and structure.
Experience with Regulatory Affairs, with primary responsibility for preparing regulatory submissions for Class III devices
Electrophysiology or related life science experience
Regulatory Affairs Strategist (Remote Position)
By Navitas Life Sciences At Princeton, NJ, United States
Minimum Required Education and Experience:
oncology, Process and Change Management, KPIs and Metrics, Project Management
Location – US (Remote opportunity)
Responsibilities Includes but not limited to:
10 to 15 years’ experience
Strong Experience in Regulatory strategy in particular with
Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
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;
Regulatory Affairs Manager Jobs
By Korn Ferry At Boston, MA, United States
5+ years of experience in regulatory affairs environment in nutrition industry.
Excellent knowledge of US and Canada Food Law - Regulations.
Korn Ferry has partnered with our client on their search for the role, Regulatory Affairs Manager.
Ensure compliance of product, ingredients, and claims.
Supply regulatory support for safety files and clinical trials/protocols in order to support R&D.
Vetting and approval of all public materials, including labelling.
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 Manager Jobs
By Jobot At New York, NY, United States
Strong knowledge of OTC drug and device regulations, including labeling requirements
Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
Working knowledge of U.S. clinical research and claims support
Excellent written and verbal communication skills
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
Drug or medical device submission and/or maintenance experience
Program Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At United States
Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
Many years in complex projects or programs including first experience in portfolio management.
Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
Experienced in strategic planning and risk management.
MS Project and project management tools.
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
Rn - Registered Nurse - Quality Improvement - Regulatory Affairs - Am
By University of Alabama at Birmingham At , Birmingham

Pay Range: $60,835.00 - $98,855.00 / Year

Regulatory Affairs Manager Jobs
By Brunel At Dallas-Fort Worth Metroplex, United States
5+ years of progressive regualtory affairs experience
Submissions experience - EU and International markets
Oversee the regualtory function for full product portfolio, managing a team, department and budget
Coordinate regulatory submissions in US and OUS markets
Provide regulatory input/support for audits
Regulatory strategy for product development
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