Director, Global Regulatory Affairs – CMC

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The Global CMC Regulatory Affairs Director is responsible for developing global CMC regulatory strategies and content plans according to scientific/risk-based regulatory strategies.

Principal responsibilities:

Regulatory Strategy

• Develop and execute global CMC regulatory strategy for one or more product(s).
• Refine regulatory strategy as new data become available and re-assess as necessary.
• CMC Regulatory Lead on CMC Teams.
• Represent CMC Regulatory viewpoint and expertise on the CMC/VST 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 Quality Target Product Profile.
• Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed.

Submissions

• Work with the CMC team to develop CMC content and submission plans; able to prioritize based on business impact.
• 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 and post approval variations).
• Work with the GRT to develop global marketing approval submission plan and timing, complying 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.
  • Lead meetings with Health Authorities.
  • Ability to negotiate with HA personnel.
• 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 health authority 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.
• Conduct due diligence assessment on behalf of CMC RA based on the Due Diligence

Qualifications - External

Education:

• Bachelors of Science in engineering, biological, pharmaceutical, or chemical sciences with generally a minimum of 12+ years of experience inclusive of post graduate education and/or in pharmaceutical or health care industry experience is required.
• MS, Ph.D., or Pharm. D. degree preferred.

Required:

• Strong people management skill is required.
• High-level verbal and written communication skills and strong attention to detail is required.
• Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to project teams; recognizes global regulatory impact is required.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results is required.
• Experience leading interactions with Health Authorities is required.
• Strong knowledge of global HA laws, regulations, guidance, and global regulation submission routes available for new study drugs is required.
• Detailed understanding of competitors in the area and what they are doing in early/late development is required.
• Solid understanding of biology, chemistry, and/or engineering relevant to pharmaceutical industry is required.
• Experience developing regulatory strategies and seen as an expert on product development and how it is applied in global regulatory strategy is required.

Other:

• This position will require approximately 10-20% travel, both International and Domestic.