Regulatory Strategy Director

Regulatory Strategy Director
San Francisco, California
March 29, 2024
$15 - $25 / hour
Internship
Urgent
Application ends: May 9, 2025
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Job Description

We are seeking an experienced and visionary Regulatory Strategy Director to lead the development and execution of regulatory strategies for our products in the medical device, pharmaceutical, and biotech sectors. This high-impact role involves shaping regulatory approaches, managing submissions, and collaborating with key stakeholders to ensure successful product approvals globally. The ideal candidate will have a proven track record in regulatory affairs leadership and strategy development.

Key Responsibilities:

  • Develop and oversee comprehensive regulatory strategies to ensure successful and timely product approvals in global markets.
  • Lead regulatory submission processes, including NDAs, BLAs, 510(k)s, PMAs, and CE Mark applications, in compliance with applicable guidelines.
  • Act as the primary liaison with regulatory authorities, fostering productive relationships and managing complex discussions.
  • Stay ahead of regulatory trends and changes, providing guidance to internal teams and adjusting strategies as needed.
  • Collaborate with R&D, clinical, and manufacturing teams to integrate regulatory considerations into product development plans.
  • Manage a team of regulatory professionals, providing mentorship and ensuring alignment with organizational goals.
  • Represent the company in industry forums, conferences, and regulatory meetings.

Qualifications:

  • Master’s degree in Life Sciences, Regulatory Affairs, or a related field (Ph.D. or MBA preferred).
  • 8+ years of experience in regulatory affairs, with at least 3 years in a leadership or strategic role.
  • Deep knowledge of FDA, EMA, and other international regulatory requirements and approval pathways.
  • Proven ability to manage complex regulatory projects and deliver results on time.
  • Strong leadership, communication, and negotiation skills.
  • Strategic thinker with the ability to balance long-term goals with immediate priorities.

Benefits:

  • Highly competitive salary with performance-based bonuses.
  • Comprehensive health, dental, and vision insurance.
  • Opportunities for professional development and global networking.
  • Leadership role in an innovative and fast-paced organization.

How to Apply:
Submit your resume and a cover letter detailing your regulatory strategy experience, leadership qualifications, and vision for this role.