Sr​/Exec Director, Regulatory Affairs; remote Int’l Biotech Expanding US Pre

Cornerstone Search Group has been retained by an attractive and well-funded clinical-stage European biotech company that is expanding its global presence here in the U.S. They are seeking to hire an experienced Regulatory Affairs professional to help the organization reach its key milestones and continue to pave the path forward in its expansion and innovative new products within the women’s health space and other areas.

The right person for this will be someone who is very hands‑on and comfortable working in a fast‑paced true biotech environment where things are still evolving. This is a visible role where you will be relied upon by the company’s senior leadership (based in EU) for your US regulatory/market expertise. Someone who has an innovative/creative mindset, and has guided new assets through various approval stages, strong experience leading meetings with FDA as well as regulatory submissions, digital innovation, etc.

In addition, you will be joining at an ideal time; as there is a clear internal path to the RA Head.

• Unique Opportunity:
  Step into a role where you will have an enormous impact on the company’s short/long‑term success here in the U.S. They want someone who will look at this as a long‑term home who will embrace internal opportunities (leadership) and play a key role in helping to evolve the organization.
• Clear internal advancement track: A great time to join, as there is a clear path to RA Head here in the U.S.
• “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 with a successful heritage.
• Impact & Visibility:
  As an international company starting to expand/grow its presence in the US, you will be an integral part of leading this success journey while working closely with the CEO, CSO and other executive leadership.
• Great Company Culture (European):
  Our client prides itself on having an excellent work culture – collaborative, forward‑thinking, inclusive, and a strong multicultural feel.

This is a remote‑based role. Must have the flexibility to travel to their European HQ a few times per year.

• Reporting to the Chief Scientific Officer, provide leadership in regulatory activities for programs in development, including global regulatory strategy and submissions, and managing critical health authority interactions.
• Provide 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.
• Establish and maintain excellent relationships with FDA and regulatory agency personnel. Negotiate directly with regulatory authorities regarding filings and proactively address inquiries and facilitate 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.

• Bachelor’s degree in a scientific field is required; advanced degree (PhD, Pharm
  
  D, MS) is preferred.
• 10+ years of progressively responsible regulatory experience in the Pharmaceutical/Biotech industry with a focus on new clinical assets (versus post‑market).
• Experience working in small/mid‑size biotech companies is strongly preferred.
• Women’s Health therapeutic experience is preferred.

E:

P: 973‑656‑0220 x738

1200 Morris Tpke, Suite 3005 | Short Hills, New Jersey (USA)