Senior Director Regulatory Affairs - San Francisco, United States - Meet Recruitment

Meet Recruitment San Francisco, United States

3 weeks ago

Description

This range is provided by Meet. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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

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).
Seniority level

Seniority level

Director
Employment type

Employment type

Full-time
Job function

Job function

Strategy/Planning and Science
Industries

Biotechnology Research and Pharmaceutical Manufacturing
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Senior Director Regulatory Affairs - San Francisco, United States - Meet Recruitment

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