Vice President Regulatory Affairs

Meet Life Sciences; Fremont (CA); Hybrid; USD 180,000 - 250,000; Full time

Job summary

A leading biotechnology company is looking for a Vice President of Regulatory Affairs to oversee global regulatory strategies. This role involves ensuring compliance with regulations, leading agency interactions, and guiding cross-functional teams to enhance product development and commercialization. The ideal candidate should possess extensive regulatory experience and a strong leadership background.

Qualifications

• Minimum of 15 years of regulatory affairs experience in the biopharmaceutical industry.
• In-depth knowledge of FDA, EMA, and ICH guidelines.
• Proven track record of securing regulatory approvals for innovative Cell therapy or Biologics products.

Responsibilities

• Formulate and implement global regulatory strategies aligned with business objectives.
• Oversee regulatory filings including INDs, NDAs, and BLAs.
• Lead communications with regulatory authorities and ensure compliance.

Skills

Leadership

Regulatory Strategy

Compliance Oversight

Interpersonal Skills

Education

Bachelor's degree in a scientific discipline

Ph.D., PharmD, or equivalent

Job description

Position : Vice President of Regulatory Affairs

Location : San Francisco Bay Area (Also open to remote)

About the Company : A biotechnology company pioneering the development of hematopoietic stem cell (HSC) therapies aimed at treating a broad spectrum of severe and life-threatening diseases. By generating self-renewing blood stem cells, this platform technology aspires to provide patients with rapid and widespread access to consistent, durable, HLA-compatible, transgene-free blood stem cell therapies. This ground-breaking approach has the potential to cure more than 70 diseases, eliminating the reliance on donor or patient cells.

About the Role : The company is seeking an experienced and strategic Vice President of Regulatory Affairs to lead and oversee all regulatory activities. This executive will be responsible for developing and executing comprehensive global regulatory strategies, ensuring compliance with all applicable regulations, and facilitating the advancement of innovative HSC therapies from development through approval and commercialization. The VP of Regulatory Affairs will serve as the primary liaison with regulatory agencies and will provide strategic guidance to cross-functional teams to achieve regulatory objectives.

Responsibilities :

1. Regulatory Strategy Development: Formulate and implement global regulatory strategies that align with business objectives and product development plans.
2. Regulatory Submissions: Oversee the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, BLAs, CTAs, and MAAs, ensuring timely and successful approvals.
3. Agency Interactions: Act as the primary point of contact with regulatory authorities, leading communications, negotiations, and meetings to facilitate product development and approval processes.
4. Compliance Oversight: Ensure adherence to all relevant regulatory requirements and guidelines, maintaining up-to-date knowledge of changes in regulations that may impact the company's products and operations.
5. Cross-Functional Collaboration: Work closely with internal teams, including R&D, Clinical, Quality, and Commercial, to provide regulatory guidance and support throughout the product lifecycle.
6. Team Leadership: Build, mentor, and lead a high-performing regulatory affairs team, fostering a culture of excellence, collaboration, and continuous improvement.
7. Risk Assessment: Identify potential regulatory risks and develop mitigation strategies to ensure successful product development and commercialization.

Qualifications :

1. Educational Background: Bachelor's degree in a scientific discipline is required; an advanced degree (Ph.D., PharmD, or equivalent) is preferred.
2. Experience: A minimum of 15 years of regulatory affairs experience in the biopharmaceutical industry, with a proven track record of securing regulatory approvals for innovative Cell therapy or Biologics products.
3. Expertise: In-depth knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines, with experience in managing complex regulatory projects.
4. Leadership Skills: Demonstrated ability to lead and develop high-performing teams, with excellent communication, negotiation, and interpersonal skills.
5. Strategic Thinking: Strong analytical and problem-solving abilities, with the capacity to develop and execute effective regulatory strategies that align with business goals.
6. Adaptability: Ability to navigate a dynamic and fast-paced environment, managing multiple projects and priorities effectively.

Pay range and compensation package: Pay range or salary or compensation

Equal Opportunity Statement: Include a statement on commitment to diversity and inclusivity.