Head, Regulatory Affairs
Description
Cornerstone Search Group has been retained by an attractive and well-funded international biotech company that has been expanding its presence here in the U.S. The company is at a key inflection point as they are focused on advancing in clinical development toward eventual commercialization within the Women’s Health therapy area. This is a very visible and highly impactful role reporting directly to the Chief Scientific Officer where you will provide hands-on Regulatory Affairs leadership for key development programs within the innovative medicines/new product development phase, as well as leading regulatory submissions and all direct interactions with the FDA and regulatory agency personnel.
Given the smaller company environment, our client is seeking someone who is flexible, forward-thinking, embraces the startup biotech type of environment, and is just as comfortable being a hands-on doer as he/she is in a big-picture strategic leadership capacity. This is a great opportunity to join an exciting and well-funded company at an important time in its growth where you will have the ability to truly impact/influence the company’s overall strategy, direction, and continued success.
Location
This is a remote-based position; the strong preference is for this person to live on the East Coast.
Features
- Unique Hands-on Leadership Opportunity: As the head of the company’s Regulatory Affairs New Product Development area, this is an excellent platform to showcase/utilize/leverage your strategic and tactical RA expertise to directly impact the company’s continued success and presence in the women’s health therapy area.
- “Best of Both Worlds”: The company offers all the attractive features sought with a smaller clinical-stage Biotech (small team camaraderie, impact, agile, swift decision-making, minimal bureaucracy), while also getting the stability and financial security of an established parent company.
- Important Inflection Point: This is an important time in the company’s evolution, as they are focused on progressing forward in development toward future commercialization. You will be an extremely important/integral member of this journey to success.
- Great Company Culture: Work for a company that prides itself on having an excellent work culture (which we’ve seen first-hand) – collaborative, autonomous, forward-thinking, creativity, and inclusive where people are engaged, enthusiastic, and have a patient-focused mindset.
Responsibilities
- Reporting to the Chief Scientific Officer, you will provide leadership in regulatory activities for programs in development, including developing global regulatory strategies, leading submissions, and managing/leading critical health authority interactions.
- Provides hands-on leadership in Regulatory Affairs, offering both strategic and tactical support for development assets in the women’s health therapeutic area. Represent Regulatory Affairs on new product/project development teams ensuring alignment with regulatory requirements and advancing the development of clinical assets.
- Navigate global health authority interactions, lead cross-functional teams, and drive clinical submissions.
- Partner with internal senior leadership to align closely on cross-functional global regulatory plans and the company's short and long-term strategic objectives.
- Provide overall management and regulatory leadership for the projects developed for the US market. This includes the filing and assessment process for the projects, and to act as the main contact with FDA and to develop the regulatory strategy.
- Provide oversight of external partners and deliverables to ensure compliance with regulatory requirements and alignment with global regulatory strategy.
- Establishes and maintains excellent relationships with FDA and regulatory agency personnel. Negotiates directly with regulatory authorities regarding filings and proactively addresses inquiries and facilitates effective communication throughout the regulatory review process.
- Provide regulatory expertise, advice, and requirements for pre-clinical and clinical disciplines, in support of drug candidates under development.
- Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations.
- Provide leadership and oversight of the preparation of all critical global regulatory submissions) to the FDA, EMA, and other international health authorities.
- Act as the primary liaison with regulatory authorities.
Qualifications / Requirements
DESIRED BACKGROUND & EXPERIENCE:
- Bachelor's degree in a scientific field is required; advanced degree (PhD, PharmD, MS) is preferred.
- 10-15+ years of progressively responsible regulatory experience in the Pharmaceutical/Biotech industry with extensive experience in Regulatory strategy. Experience working in small/mid-size biotech companies is strongly preferred.
- A proven track record leading/managing direct communications/interaction/negotiations with the FDA and regulatory agency personnel.
- Regulatory Affairs experience in the Women’s Health therapy area is preferred.
- Willingness to travel to key meetings and Health Authority interactions as needed.
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