Global CMC Regulatory Affairs Associate
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Global CMC Regulatory Affairs Associate located in either Titusville, NJ or Raritan, NJ with a minimum of 10% domestic and international travel.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Global CMC Regulatory Affairs Associate contributes to the development of global CMC regulatory strategies and content plans. Ensures the development strategy meets global regulatory requirements over the lifecycle of the product as well as regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile (TPP). Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).
Participates as the Regulatory CMC Lead on CMC Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations. Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product. Prepares regulatory dossiers for submission to Health Authorities. Actively participates on Global Regulatory Team(s) to develop global marketing approval submission plans. Provides accurate regulatory assessments of chemistry manufacturing and control changes to teams and executes regulatory planning and implementation.
• Contributes to the development of global CMC regulatory strategies and content plans for one or more product(s)
• CMC Regulatory Lead on CMC Teams
• Represent CMC Regulatory viewpoint and expertise on the CMC Team, Global Regulatory Team, including regulatory risk assessments and mitigations associated with proposed strategies
• Develop and update contingency plans for issues that affect registration, regulatory compliance and continued lifecycle management of the product
• Confirm CMC strategy is in alignment with Therapeutic Area, regional strategies, commercial strategy, and Target Product Profile
• Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed
• Work with the CMC team to develop CMC content and submission plans
• Prepare regulatory (CMC) sections of development/project plans and provide strategy as issues arise to gain rapid approval with reasonable risk
• Provide input to and be accountable for the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IRD/IND/CTA)
• Work with the GRT to develop global marketing approval submission plan and timing
• Work with GRT to comply with local regulatory requirements and commitments
Health Authority Interactions:
• In collaboration with Regional and/or local Regulatory Leader, as applicable:
• Determine timing and strategy for HA meetings
• Prepare company staff for interactions
• May contact HA under supervision
• Develop strategy for providing responses to HA questions (ensure alignment with global strategy)
• Effectively and tactfully communicate with HA; maintain good rapport and credibility with HA
• Provide CMC Regulatory support to pre-approval and GMP inspections
Regulatory Input into Other Functions:
• Conduct regulatory assessments of CMC change controls
• Work with the GRT to provide CMC input to global regulatory strategy and submission plans
• Provide input to pharmaceutical development, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy
• Work with GRT to direct, manage and resolve any issues
• A minimum of a Bachelor's Degree with 4+ years of experience, OR a Master's Degree with 2+ years of experience, OR a Ph.D. with 0/1 years of experience is required
• Demonstrated ability to communicate regulatory requirements is preferred
• Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to corporate project teams is required
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results is required
• Working knowledge of global HA laws, regulations, and guidance is preferred
• Experience developing regulatory strategies and an understanding of product development is preferred
• Solid understanding of biology and chemistry relevant to therapeutic area is preferred
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Titusville
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
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