VP/ED, Regulatory Affairs (Innovative Products)
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 advancing in clinical development toward eventual commercialization, and they are seeking to hire an experienced Regulatory Affairs leader to help the organization reach its goals and continue to look toward the future.
Our client is seeking someone who is flexible, hands-on/enjoys rolling up their sleeves, and is comfortable working in a smaller company environment where things are continuing to evolve. The ideal background for this is someone who has proven experience in small/mid-size companies, new product development (pre-IND through clinical development/NDA), who has led meetings/negotiations with regulatory agencies/health authorities and global submissions, and has experience working in the Women’s Health therapeutic area.
Location
This is a remote-based position. The preference is for EST/CST.
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 short/long-term success.
- “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 very successful heritage.
- Key Role in this Success Journey and Beyond: This is an important time in the company’s evolution and expansion, 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 filling 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.
- Regulatory Affairs leadership experience working in the Women’s Health area (reproductive health, fertility, contraceptives, etc.) is required.
- A proven track record leading/managing direct communications/interaction/negotiations with regulatory agencies/Health Authorities i.e. FDA, Health Canada, etc.
- Willingness to travel to key meetings and Health Authority interactions as needed.
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