Senior Director Regulatory Affairs

3 weeks ago


Palo Alto CA, United States Meet Recruitment Limited Full time

Job Title: Senior Director of Regulatory Affairs (Oncology Focus)

Location: San Francisco Bay Area

About Us:

We are parntered with a dynamic and innovative biotechnology company dedicated to transforming the landscape of oncology treatment. With a passion for delivering groundbreaking therapies to patients in need, they have successfully brought a pioneering oncology product to market and are poised for continued growth and success.

Position Overview:

They are seeking a highly motivated and experienced Senior Director of Regulatory Affairs to join our team. In this critical role, you will lead and oversee all regulatory activities related to our oncology-focused product, ensuring compliance with regulatory guidelines and facilitating its continued success in the market. As a key member of our Regulatory Affairs team, you will have the opportunity to shape the regulatory strategy, drive submissions, and play a pivotal role in the development and lifecycle management of our oncology product.

Key Responsibilities:

Regulatory Strategy Development: Develop and execute comprehensive regulatory strategies for the company's oncology product, encompassing global markets.

Regulatory Submissions: Lead the preparation, submission, and maintenance of regulatory filings, including INDs, BLAs, NDAs, and other relevant documents. Ensure submissions are accurate, complete, and compliant with regulatory requirements.

Agency Interactions: Build and maintain strong relationships with regulatory agencies (FDA, EMA, etc.) and represent the company in regulatory meetings and negotiations.

Compliance: Stay current with regulatory guidelines and industry best practices to ensure continuous compliance. Provide guidance to cross-functional teams on regulatory matters.

Labeling and Packaging: Oversee the development and review of product labeling, packaging, and promotional materials to ensure they meet regulatory standards.

Life Cycle Management: Develop and implement strategies for product lifecycle management, including post-marketing regulatory activities, variations, and label updates.

Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Clinical Development, Quality Assurance, Medical Affairs, and Commercial, to align regulatory strategies with business goals.

Team Leadership: Provide leadership and mentorship to the regulatory affairs team, fostering a culture of excellence and growth.

Risk Assessment: Identify and assess regulatory risks and propose mitigation strategies to senior management.

Qualifications:

  • A minimum of 8 years of regulatory affairs experience in the biopharmaceutical industry, with a strong focus on oncology products.
  • Proven track record of successfully leading regulatory submissions and interactions with regulatory agencies.
  • In-depth knowledge of FDA and international regulatory requirements for oncology products.
  • Strong leadership and team management skills.
  • Excellent communication, negotiation, and problem-solving abilities.
  • Bachelor's degree in a relevant scientific field (advanced degree preferred).
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