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We are searching for a Regulatory Affairs Manager- Gene Therapy for a a small preclinical startup focused on advancing innovative therapeutics in the biotech industry. The Regulatory Affairs Manager- Gene Therapy will be leading regulatory strategy and driving the successful development of therapeutic candidates through preclinical and clinical stages. This person must live in Southern CA, either San Diego or Los Angeles.
Requirements for the Regulatory Affairs Manager- Gene Therapy:
  • Bachelor’s and advanced degree in life sciences, pharmacy, or a related field is preferred.
  • 5+ years’ experience in regulatory affairs within the biotech or pharmaceutical industry, with a focus on IND submissions and Phase I and Phase II clinical trials.
  • Experience with gene therapy.
  • Demonstrated track record of successfully leading regulatory submissions, including IND applications and interactions with regulatory authorities.
  • In-depth knowledge of FDA regulations, guidelines, and procedures relevant to drug development and clinical trials.
  • Strong understanding of the drug development process, including preclinical, clinical, and regulatory requirements.
  • Proven ability to develop and implement regulatory strategies
  • Strong communication and interpersonal skills, with the ability to effectively collaborate and influence cross-functional teams and build relationships with regulatory authorities.
  • Strong leadership skills
  • Detail-oriented with excellent organizational, project management, and problem-solving abilities.
  • Ability to work in a fast-paced, dynamic startup environment and adapt to changing priorities and deadlines.
Responsibilities of the Regulatory Affairs Manager- Gene Therapy:
  • Develop and execute regulatory strategies to support the advancement of our therapeutic candidates from preclinical to clinical stages, ensuring compliance with applicable regulations and guidelines.
  • Lead the preparation, submission, and management of IND applications and regulatory documentation for clinical trials, collaborating with cross-functional teams to ensure timely and high-quality submissions.
  • Serve as the primary point of contact for regulatory agencies, fostering strong relationships and effectively communicating with regulatory authorities to address questions, provide necessary information, and resolve issues.

Occupational Category: 11-9199.01 Regulatory Affairs Managers

Application Instructions: Please apply using the form or send your resume to Surf Search.

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