Dir/Sr. Dir (Head), Regulatory Affairs
Description
Cornerstone Search Group has been retained by an attractive and well-funded clinical-stage biopharmaceutical committed to the advancement of innovative products within the women’s health area. The company is at a key inflection point as they are focused on progressing through clinical development toward eventual commercialization. They are seeking to hire an experienced Regulatory Affairs leader to help the organization reach its key milestones and continue to pave the path forward in expanding its presence in the US.
The right person for this will be someone who is very hands-on/enjoys rolling up their sleeves (as opposed to more of a delegator) and is comfortable working in a smaller company environment where things are still evolving. Someone with extensive experience focused in new/innovative product development (discovery, pre-IND through clinical development/CMC to NDA registration), who has managed global submissions and has been the Regulatory lead having successfully guided new assets through various approval stages, who has led meetings/negotiations with health authorities (particularly the FDA), and experience working in small/mid-sized companies vs purely big pharma.
Location
This is a remote-based position. You will need the flexibility to travel to their global HQ a few times per year.
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 have an enormous impact on the company’s short/long-term success. They want someone who will look at this as a long-term home.
- “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 with a marketed product and a successful heritage.
- Highly Visibility: As an international company starting to expand/grow its presence in the US, you will be an extremely important/visible member who will be relied upon to help lead this journey.
- Great Company Culture: Our client prides itself on having an excellent work culture (which we’ve seen first-hand) - collaborative, forward-thinking, inclusive, and a strong multicultural feel.
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 a focus on new clinical assets (versus post-marketed).
- Experience working in small/mid-size biotech companies is strongly preferred.
- Experience developing global regulatory strategies, leading global submissions, and has been the Regulatory lead having guided products from pre-IND through clinical development to successful registration/approval.
- Must have a proven track record leading/managing direct communications/interaction/negotiations with regulatory agencies/Health Authorities (especially the FDA).
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