DUTIES AND RESPONSIBILITIES:
Develop and implement regulatory affairs strategies and tactical work plans during clinical development and in preparation for the anticipated US filings.
Identify and assess regulatory risks, understanding global imperatives including market-related drivers.
Keeping up with US and global regulatory requirements and guidance, and providing oversight and review of key regulatory documents.
Present and defend regulatory plans to senior management.
Lead the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, BLAs, fast-track/breakthrough/accelerated approval/orphan drug applications.
Fulfill requirements for ensuring all reporting obligations are met, including amendments, annual reports to FDA, safety and quality reports.
Interact with clinical operations leadership of channel partners.
Foster, build, and support collaborative relationships at all levels of the organization as well as with external constituents.
Build and foster a world-class regulatory function through mentoring and developing employees and recruiting top talent.
EDUCATION AND EXPERIENCE:
Master’s or Ph.D. in Molecular Biology, Pharmaceutical Sciences or Life Sciences.
A minimum of 5 years regulatory experience in biotech programs within the FDA, industry or combination.
The ideal candidate will have experience with gene modified T cell products (CAR-T, TCR), non-viral and viral vector products, and gene therapy design and antibodies.
Recent experience with IND, NDA and BLA submissions is a must. Experience in biologics is preferable.
Thorough understanding of the FDA (biologics division.)
Results oriented. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
DESIRED KEY COMPETENCIES:
Excellent communication skills.
Self-motivated and independently minded.
Ability to understand and effectively communicate scientific and medical information to both internal and external customers.
Excellent written and oral communication skills are imperative.
Ability to understand the business needs of Intrexon and our channel partners.
Ability to anticipate and adapt to change while maintaining the momentum of an overall strategic plan.
Ability to work independently yet engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment.
Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
Self-organizer, meticulous hands-on habits, keen attention to detail.
Strong quantitative and analytical skills.
Responsive, can-do attitude.
Can coordinate parallel tasks across multiple projects, demonstrating prioritization.
Ability to quickly adapt to a rapidly changing environment and demands.
Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats.
- Term Entry +
- Company Intrexon