Retained Position

We have a newly created opportunity for a Sr. Global Regulatory Lead will be the primary contact for strategic oversight on the respective therapeutic area as the subject matter expert. Responsible for leading regulatory strategic decision making that enables a project to meet its business and regulatory deliverables.

Organization: My client is an established, world-class biotherapeutics organization with operations in 35+ nations and 22,000 employees worldwide. They are driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation, and burn treatment. With a passion and commitment to delivering on their promise to save and improve lives across the globe, now is an exciting time to join this team.

Responsibilities:

• Providing innovative scientific and regulatory vision, and leadership in defining aligned global regulatory strategies for assigned products within developmental portfolio and accountable for clinical and safety content globally of regulatory documentation for these projects.
• As the primary regulatory interface within for Global Regulatory Affairs (GRA) on specific projects, the incumbent will have responsibility for ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), Safety Management Team (SMT) and Commercial Development to ensure the global regulatory strategy is an integral component of stakeholder deliverables.
• For early development projects, the Sr. GRL is a company resource for global regulatory perspective and drives the GRA perspective within the company.
• The Sr. GRL leads the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy.
• In partnership with GRA Regional Leads, supporting the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies.

Qualifications and Experience:

• A bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree (MS/MBA, PhD or MD) is preferred.
• Minimum of 10 years’ experience in the biotech or pharmaceutical industry, with at least 8 years in Regulatory (with 5+ years of that time in a developmental stage organization).
• Experience in leading and managing Health Authority meetings.
• Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (i.e., EU, US, Japan)
• Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment across two or more geographic areas (preferentially US and EU), with proven skill implementing successful global regulatory strategies.
• Experience interfacing with regulatory agencies, including leading and preparing the sponsor’s team for an interaction.
• Demonstrated experience in working with multiple stakeholders, across geographies.
• Experience working in a complex and matrix environment is required.
• Prior clinical regulatory foundation is preferred.

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