Vice President/Head, Regulatory Affairs
Our client is a clinical stage biotechnology company. They have asked us to assist them in their search for a Vice President/Head, Regulatory Affairs
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Leads the regulatory affairs function, delivering strategic leadership and operational excellence, with full functional responsibilities.
- Develops regulatory strategies for projects at early stages of development, in collaboration with cross-functional members.
- Functions as the primary resource and conduit for senior leadership on all regulatory matters.
- Acts as the point of contact for all regulatory agency interactions, including the preparation and regulatory leadership for key meetings.
- Interacts with regulatory agencies with intelligence and diplomacy. Develops and maintains strong relationships with regulatory agency staff.
- Manages the preparation and timely submission of regulatory documents.
- Applies development proficiency to guide teams on broader development issues. Provides a big picture, unbiased viewpoint in all development discussions, seeking approvable development packages capable of commercial success.
- Works with third party regulatory and regulatory CMC consultants, and CRO’s to complement expertise and operational capacity.
- Functions as the authority on regulations, guidance documents, contemporary regulatory practices and relevant regulatory precedence to guide the overall development plans accordingly.
- Proactively monitors changes in the regulatory environment.
- PhD or master’s degree in a relevant scientific area is required.
- Must have 10-15 years of industry experience in drug development with progressively increasing responsibilities in regulatory affairs.
- Oncology experience with a significant level of interaction with the relevant FDA review divisions highly preferred.
- Experience working with the FDA is required.
- Global regulatory clinical trial experience and regulatory CMC experience are preferred.
- Profound regulatory experience is required, including experience with developing broad plans for phase 1 through phase 3.
- Experience with pivotal trials, product registration and NDA regulatory experience is preferred.
- Requires excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Attention to detail and quality are required.
- Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model.
- Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
- Requires proven ability to manage multiple projects and identify and resolve issues.
- Broad experience in a small company environment is preferred.
- Ability to travel up to 25% is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.