Director of Regulatory Affairs Strategy

We are partnering with an exciting oncology biotech that is looking for an accomplished Director of Regulatory Affairs Strategy to lead within their Regulatory Affairs team. The ideal candidate will be responsible for developing and executing regulatory strategies that drive the successful development, registration, and commercialization of products in their Oncology portfolio.

Responsibilities:

Develop and implement comprehensive regulatory strategies aligned with business objectives and regulatory requirements to support product development and commercialization.

Provide strategic leadership and guidance on regulatory matters to cross-functional teams, including R&D, Clinical Development, Quality Assurance, and Commercial teams, throughout the product lifecycle.

Lead regulatory interactions and negotiations with health authorities, including preparation and submission of regulatory filings, meeting packages, and responses to regulatory queries.

Stay abreast of evolving regulatory landscape and proactively assess potential impacts on product development and commercialization strategies.

Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities, ensuring compliance with applicable regulations and guidelines.

Mentor and develop regulatory affairs team members, fostering a culture of excellence, innovation, and professional growth.

Qualifications:

Bachelor's degree in life sciences or related field required; advanced degree (e.g., Master's, PhD, PharmD) preferred.

Minimum of 8 years of progressive experience in regulatory affairs and a minimum of 10 years in the pharmaceutical or biotechnology industry.

at least 5 years of regulatory in Oncology required

Expert knowledge of global regulatory requirements and guidelines for drug development and commercialization, including FDA, EMA, and other major regulatory agencies.

Proven track record of successfully leading regulatory activities for pharmaceutical products across multiple therapeutic areas and geographic regions.

Exceptional leadership, communication, and influencing skills, with the ability to collaborate effectively with internal and external stakeholders at all levels.