Headhunters, LLC's client is seeking a Sr. Manager, Regulatory Affairs.
The Senior Manager will lead regulatory activities across business units (Vaccines & Anti-Infectives, Devices, Antibody Therapeutics) as assigned. The Sr. Manager will serve as the regulatory representative on Project Teams where he/she will provide regulatory strategy, direction, support and advice to the teams. The Manager will lead the development of a sound regulatory strategy and follow-through to implementation with the project Team. The Sr. Manager will take the lead on all regulatory activities, including the management of authoring, review, and coordination of a quality submission. The Sr. Manager will prepare the team for meetings, teleconferences, and other communications (including pre-read packages and/or other necessary documentation) with FDA and other global regulatory agencies. The Sr. Manager will educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.
Responsibilities and Duties:
Lead all regulatory activities including the development of regulatory strategies for assigned products or projects
Lead the preparation of regulatory submissions including but not limited to pre-IND and formal meetings with FDA, Health Canada, EMA and other regulatory agencies, INDs/CTAs, Annual Reports, BLAs, NDAs/NDS/MAs and supplements, and routine correspondence
Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices
If assigned, Manage and lead a group of regulatory professionals within the Regulatory department
Provide critical review of all documentation supporting regulatory applications
Plan, coordinate, prepare and lead meetings and teleconferences with regulatory agencies
Lead interactions with the FDA and other regulatory agencies.
Build professional relationships with the FDA project managers and other key personnel, as appropriate.
Communicate with outside regulatory agencies regarding submissions and provide company representation with regulatory agencies to obtain expeditious approval and maintain post-approval compliance
Monitor applicable current and new regulatory requirements. Provide regulatory intelligence for project teams and product development plans.
Work closely with Regulatory Operations for timely submission of electronic and paper submissions.
Ensure FDA commitments are met in a timely manner.
Provide regulatory review, feedback and /or approval for relevant documents.
Interact with company partners and consultants for various regulatory matters as needed
Manage the regulatory strategy, timelines and cost projections for government proposals and due diligence activities.
Interact with business unit teams, other functional managers, and internal/external customers
Participate in Regulatory Department initiatives, such as process improvement projects.
Education, Experience & Skills
Bachelors degree in a life sciences or related discipline required; advanced Degree (MS or PhD) highly preferred.
Ideally a minimum of 10 years directly related experience in biotechnology or pharmaceutical industry.
Minimum of 8 years direct experience in Regulatory Affairs.
Must have previous experience interacting with FDA and other regulatory agencies.
Must have product development and/or post licensure experience within Regulatory Affairs.
RAC certification would be a plus.
Line management experience desirable.
For immediate consideration, please send your resume and cover letter to Meredith: