Director of Regulatory Affairs
Job Req code: 965
Category: Regulatory Affairs
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. The individual in this role manages and develops regulatory strategies for IND submissions to FDA as well as the overall BLA submission strategy.
Key Responsibilities include:
- Responsible for regulatory submissions for bio-technology products including cell-based and tissue derived products. Includes preparation writing and submission of IND, IND Amendments, and BLAs. Ensure that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
- Drive project teams to achieve timely submission goals, while effectively interacting with all functional areas involved in the project goal.
- Research regulatory and scientific information to develop regulatory strategies, write regulatory assessments and provide input on technical and regulatory issues to guide internal teams.
- Interact with government agencies and regulatory authorities, as necessary, 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.
- Partner with other functional areas (including Manufacturing, Quality, Marketing, Medical and Clinical Affairs, Customer Service, Legal and Compliance, Health Policy and Reimbursement) to deliver solutions to project goals and execute tactics that further business objectives in an effective and compliant manner.
- Interact with outside consulting groups and vendors to manage activities necessary for completing key initiatives.
- Provide Regulatory Affairs support for Class II and Class III medical devices and biologic and products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), including applications submitted to the FDA and other regulatory agencies.
- Work with cross functional collaborators (such as R&D and Quality) and external consultants, this individual will also advise on regulatory and scientific issues related to the development of these products.
- Participate in activities such as product design and development, risk assessments, evaluation of quality events and non-conformances, evaluation of change controls, validation and testing; determine impact on submissions and filing requirements.
- Participate in industry organizations and alliances to influence regulatory policy making and decisions that impact company operations.
- Lead and manage complex issues with multiple competing priorities that have a direct impact on operations and opportunities. Provide organization and prioritization to align with business needs.
Abilities and Skills Required:
- 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
- Bachelor’s degree in a scientific discipline
- At least 10 years' experience in the medical or life science industry with at least five years of increasingly responsible experience in Regulatory Affairs
- Solid working knowledge of device/biologic development process and of FDA regulatory requirements for biotechnology products in the U.S. required
- Must have successfully submitted regulatory filings to the FDA and other regulatory agencies.
- Experience with technical aspects of product development and manufacturing
Start a career today!
Join our team at Organogenesis! We are always looking for passionate and dedicated people to join our team. Let us know about you!