Manager/ Director, Regulatory Affairs, Couple of openings.
- Vaccine Business Unit lead â€“ vaccine focused - heavy on leadership and hands on experience through regulatory strategy and drug development. Experience in Flu vaccine preferred. CMS Fill/Finish Experience. Working in Manufacturing facility.
The Sr. Manager/Director will lead all regulatory activities for our Vaccine Business Unit and will serve as the regulatory representative on Product Development Teams where he/she will provide regulatory strategy, direction, support and advice to the teams. The Sr. Manager/ Director will lead the development of a sound regulatory strategy and follow-through to implementation to the Product Development Team.
They will take the lead on all regulatory activities, including the management of authoring, review, and coordination of a quality submission. They 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. They 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.
Major Responsibilities and Duties:
- Lead all regulatory activities for Vaccine Business Unit
- Lead the development of regulatory strategies for all vaccine products
- Lead the preparation of regulatory submissions including pre-IND and formal meetings with FDA, INDs, Annual Reports, BLAs and BLA supplements, and routine correspondence
- Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices
- 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
- 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 and cost projections for vaccine related government proposals and due diligence activities
- Interact with business divisions, other functional managers, and internal/external customers
- Monitor applicable current and new regulatory requirements
- Other duties as assigned.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
Bachelor's degree in a life sciences or related discipline required; advanced Degree (MS or PhD) highly preferred. 10+ years of industry experience in Regulatory Affairs. Must have previous experience interacting with FDA and other regulatory agencies. Must have vaccine development experience within Regulatory Affairs. RAC certification would be a plus.