Senior Director, Biologics Regulatory Affairs ( Fully Remote)

Trova Talent; San Diego (CA); Remote; USD 130,000 - 190,000; Full time

Job summary

An innovative firm is seeking a Senior Director of Regulatory Affairs to lead strategic initiatives in a fully remote role. This position involves overseeing regulatory projects, ensuring compliance with clinical and CMC requirements, and collaborating with leadership to align long-term strategies with company goals. The ideal candidate will bring over a decade of experience in regulatory affairs within the pharmaceutical or biotech sectors, demonstrating a strong technical understanding of cell therapy. Join a dynamic team where your expertise will shape the future of groundbreaking products.

Qualifications

• 10+ years of regulatory affairs experience in pharmaceutical or biotech sectors.
• Technical understanding of cell therapy is required.

Responsibilities

• Develop and implement regulatory strategies aligned with company goals.
• Lead internal teams to ensure compliance with regulatory requirements.
• Prepare regulatory documents like IND submissions and marketing applications.

Skills

Regulatory Affairs

Cell Therapy

Team Collaboration

Communication Skills

Education

PhD

MD

JD

Job description

My client is currently seeking a Senior Director of Regulatory Affairs to join their team in Southern CA (Fully Remote).

Position Overview:

This role offers an immediate opportunity for a Senior Director of Regulatory Affairs to provide strategic leadership and oversee all regulatory projects, supporting the company's registration goals. The products under development include cells and exosomes.

The Senior Director will collaborate with the leadership team to develop long-term strategies and execute short-term goals aligned with clinical and CMC requirements, in accordance with the company’s objectives.

Responsibilities:

1. Develop and implement long-term regulatory, clinical, and CMC strategies aligned with company goals.
2. Lead and collaborate with internal teams to ensure programs comply with strategies and regulatory requirements.
3. Prepare regulatory documents such as IND submissions, marketing applications, and designation requests.
4. Develop regulatory strategies and policies; lead regulatory intelligence initiatives.
5. Coordinate with CMC and clinical teams to meet regulatory requirements and ensure documentation readiness.
6. Represent regulatory affairs in internal project teams.
7. Build, manage, and lead a team of regulatory personnel and consultants.
8. Establish and maintain relationships with external regulatory authorities.
9. Plan and lead meetings with regulatory agencies.
10. Advise colleagues on regulatory matters and study conduct.
11. Coordinate global regulatory initiatives and strategic development.
12. Provide guidance on product development and clinical strategies.
13. Assist with due diligence reviews for investors and regulatory activities.
14. Develop product development plans ensuring scientific rigor and regulatory compliance.
15. Perform additional duties as required.

Requirements:

• PhD, MD, and/or JD degree is highly preferred.
• 10+ years of regulatory affairs experience in pharmaceutical or biotech sectors, including senior management roles.
• Technical understanding of cell therapy is required.
• Excellent communication skills and team collaboration abilities are essential.