This client is a leading regenerative medicine company focused on the development of biologic and combination products for advanced wound care. They are seeking a Regulatory CMC Program Manager who can develop CMC regulatory strategies and write CMC sections for IND and BLA applications. You will work closely with cross-functional teams and advise on regulatory issues while interfacing directly with the FDA. This company offers competitive compensation, a generous benefits package and a great work-life balance!
- Develop and execute on Regulatory CMC strategies for cell-based and tissue-derived products
- Write and manage submissions of CMC sections of IND and BLA applications
- Ensure that regulatory submissions are complete, properly formatted and comply with applicable regulatory requirements.
- Interact with government agencies and regulatory authorities to facilitate submission review and product approvals, maintain compliance, and communicate pertinent information.
- Plan and participate in meetings with FDA and provide regulatory support for inspections by government and other regulatory authorities.
- Develop and manage project plans to meet Company objectives and further business. Provide regulatory insight to inform business planning and strategies.
- Partner with other functional areas (Manufacturing, Quality, Marketing, Medical and Clinical Affairs, etc.) to deliver solutions to business problems in an effective and compliant manner.
- Monitor, identify and communicate new and relevant changes in applicable regulations, guidance, standards, other applicable regulatory policies.
- Provides insight to Regulatory Department and cross-functional teams to ensure compliance with new requirements and promote continuous improvement and current best-practices.
Knowledge and Skills:
- BS degree in life sciences or related scientific discipline. Advanced degree (MS, PhD, PharmD) preferred.
- At least six years’ experience with at least five years in Regulatory Affairs.
- Must have experience writing and managing CMC sections of INDs, CTAs, NDAs, and/or BLAs for biologic or small molecule drug programs in development.
- Solid working knowledge of biologic development process and of FDA regulatory requirements for biotechnology products in the U.S.
- Experience with technical aspects of product development and manufacturing.
- Experience interacting with health authorities and responding to FDA queries.
- Strong oral and written communication skills, and negotiation skills.
- Willing to set and drive aggressive project timelines.
- Capable of strategic thinking and proposing innovative solutions to regulatory problems.
- A team player, who listens effectively.
NOTE: All candidates must be authorized to work in the United States. Our client cannot provide H1B visa sponsorship or a transfer. However, they can provide relocation assistance if needed.