Janssen Research & Development, LLC. is recruiting for a CMC Regulatory Affairs Associate. This position can be located in Leiden, the Netherlands; Cork, Ireland; High Wycombe, United Kingdom; or Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research and Development, LLC. is part of the Janssen Pharmaceutical Companies.
The CMC Regulatory Affairs Associate contributes to the development of global CMC regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other CMC RA personnel.
Your main responsibilities will be:
Regulatory Strategy
- Assists in the execution of a CMC strategy that is in alignment with Therapeutic Area, regional strategies, commercial strategy, and Quality Target Product Profile.
- May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds and marketed products.
- Under the direction of other CMC RA personnel may participate on CMC/GRT/VCT teams.
- Assists in the execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
- Assists in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
Submissions
- Works with the CMC/GRT/VCT teams or other CMC RA personnel to develop CMC content and dossier plans.
- Prepares regulatory (CMC) sections of development/project plans and adapts strategy as issues arise to gain rapid approval with reasonable risk.
- Provides input to and assists in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post-approval variations).
- Coordinates the preparation of country-specific required documentation to support global submissions.
- Assists with CMC RA submissions for renewals, annual product submissions, and questions from LOC partners/health authorities/other J&J partners.
- Works with other CMC RA personnel to develop a global marketing approval submission plan and timing per the GRT.
- Works with other CMC RA personnel to assure compliance with local regulatory requirements and commitments per the GRT.
Health Authority Interactions
- Assists in preparing responses to HA communications/questions in alignment with global strategy.
- Provides CMC Regulatory support to HA inspections.
Regulatory Input into Other Functions
- Assists in or conducts regulatory assessments of CMC change controls.
Qualifications
Qualifications
Education:
- Bachelor of Science in engineering, biological, pharmaceutical, or chemical sciences with generally 4-6 years of experience inclusive of post-graduate education and/or pharmaceutical or healthcare industry experience is required.
- MS, Ph.D., or Pharm.D. degree preferred.
Required:
- Prior drug development, analytical development, or manufacturing experience is required.
- Demonstrated ability to communicate regulatory requirements is required.
- Good verbal and written communication skills, good organizational skills, and strong attention to detail are required.
- Communicates cross-functionally and cross-company as well and presents CMC management-approved regulatory strategy and opinion to project teams required.
- Demonstrates model behavior that understands what the priorities are and encourages others to aim for the required results.
- A solid understanding of global HA laws, regulations, and guidances is required.
- An understanding of product development is required.
- A solid understanding of biology, chemistry, and/or engineering relevant to therapeutic areas is required.
Other:
- This position will require approximately 5% travel, domestic and/or international.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
