Regulatory Affairs Manager
We are currently seeking a seasoned Regulatory Affairs (RA) Professional to lead strategic, operational and functional needs in RA and to help support the Chief Scientific Officer and Chief of Staff with the preparation of regulatory applications, as well as coordination with vendors and collaborators with cGMP-compliant work.
Duties and Responsibilities
Specifically, you will be responsible for:
- Write and edit Pre-IND, IND, BLA, etc applications.
- Communicate with teams on Regulatory requirements to both update data and protocols.
- Coordinate with established regulatory consultants understand when and where external expertise is needed.
- Keep abreast of the latest regulatory pathways, regulations, guidelines, and opportunities.
- Identify and assess and communicate regulatory risks for assigned projects or programs.
- Coordinate this work with other funding opportunities, including BARDA, DoD, etc.
- Communicate with regulatory agencies relevant to assigned projects, as appropriate.
- Prepare IRB protocols associated with applications.
- Manage and maintain documentation for regulatory inspections, audits, etc.
- Coordinate with external collaborators on cGMP-compliance paperwork, etc needed for applications, grants.
- Establish and maintain communication between teams and external collaborators in regard to regulatory tasks, deliverables, and cGMP-compliance needs.
- Participate in negotiations with potential cGMP-compliant collaborators.
- Collaborate with domestic and international colleagues regarding license renewals and updates.
- We’re a startup – every day is different!
- Communicate with upper management and board members on regulatory affairs process.
- Maintain regulatory files and databases as required.
- Mentor other personnel on regulatory applications, processes, pathways, etc.
- M.S. in relevant field and at least 7 years of relevant experience required, with 10+ years preferred.
- Experience in cell-based and/or drug delivery therapeutics is preferred.
- Strong knowledge of US drug and biologic regulations as well as ICH and US guidance documents.
- Familiarity with eCTD publishing systems and requirements.
- Experience in comparable roles in startups and/or biotechnology with domestic and international regulatory standards required.
- Can work productively and develop cohesive team relationships.
- Ability to manage change with a positive proactive approach.
- High degree of computer literacy in Mac/PC based OS environments.
- Good oral and written communication skills.
- Must be able to logically and effectively structure tasks and set priorities.
- Medical, Dental, Vision Insurance
- Retirement Planning (401k)
- Unlimited vacation/sick days
- Parental Leave
- Commuter Discounts and much more!