Regulatory CMC Program Manager

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!

Responsibilities: 

  • 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.

Apply for this Position



Your Name*

Your Email*

Resume

Your Message

This entry was posted in . Bookmark the permalink.