- Responsible for regulatory submissions for bio-technology products including cell-based and tissue derived products. Includes preparation writing and submission of IND and BLA applications as well as other submission types for products approved/cleared through PMA and 510(k) pathways. Ensure that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
- Research regulatory and scientific information to develop regulatory strategies and provide input on technical issues (e.g. review validation and testing strategies and reports) 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.
- 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 (including Manufacturing, Quality, Marketing, Medical and Clinical Affairs, Customer Service, Legal and Compliance, Health Policy and Reimbursement) to deliver solutions to business problems and execute tactics that further business objectives 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
- Collaborate with Quality Systems to manage and maintain compliance of systems and processes with GMP/ QSR requirements, applicable international requirements and industry standards. Development, writing and review of SOPs and protocols to ensure regulatory compliance.
- Participates in activities such as product design and development, risk assessments, evaluation of quality events and non-conformancies, 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/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.
- Interact with outside consulting groups and vendors to manage activities necessary for completing key initiatives.
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 responsibleexperience 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 working on INDs and BLA submissions strongly preferred
- Experience with technical aspects of product development and manufacturing