Barrington James
Senior Manager Regulatory Affairs (Contract)
Barrington James, San Jose, California, United States, 95199
Senior Manager Regulatory Affairs (Contract)
We’re looking for a
high level regulatory affairs professional
to lead a regulatory team at a new biopharmaceutical company based in San Jose, CA.
In this role, you will play a crucial part in ensuring the biotechnological advancements comply with all relevant regulations and standards. Working closely with cross‑functional teams to guide product development and market entry strategies while maintaining compliance and transparency with regulatory authorities.
The role will require a minimum of 3 days a week of onsite presence (or more if current project needs require).
Responsibilities
Regulatory Strategy:
execute regulatory strategies to support product development, approval, and commercialization, ensuring alignment with the company's goals and objectives.
Regulatory Compliance:
stay current with all relevant regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to applicable regulatory requirements.
Submission management:
prepare, review, and submit regulatory documents, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
Cross‑Functional Collaboration:
collaborate closely with R&D, Quality Assurance, Clinical Development, and other teams to provide regulatory guidance and ensure that regulatory considerations are integrated into product development.
Quality Assurance:
oversee regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
Requirements
Post‑Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant scientific discipline.
Strong knowledge of FDA and international regulatory requirements and guidelines.
Excellent communication, negotiation, and project management skills.
Ability to work effectively in a cross‑functional team environment.
Attention to detail, strong analytical skills, and problem‑solving abilities.
Adaptable and able to thrive in a fast‑paced, high‑growth environment.
If you think you're a good fit and looking for a new challenge, apply now.
#J-18808-Ljbffr
high level regulatory affairs professional
to lead a regulatory team at a new biopharmaceutical company based in San Jose, CA.
In this role, you will play a crucial part in ensuring the biotechnological advancements comply with all relevant regulations and standards. Working closely with cross‑functional teams to guide product development and market entry strategies while maintaining compliance and transparency with regulatory authorities.
The role will require a minimum of 3 days a week of onsite presence (or more if current project needs require).
Responsibilities
Regulatory Strategy:
execute regulatory strategies to support product development, approval, and commercialization, ensuring alignment with the company's goals and objectives.
Regulatory Compliance:
stay current with all relevant regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to applicable regulatory requirements.
Submission management:
prepare, review, and submit regulatory documents, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
Cross‑Functional Collaboration:
collaborate closely with R&D, Quality Assurance, Clinical Development, and other teams to provide regulatory guidance and ensure that regulatory considerations are integrated into product development.
Quality Assurance:
oversee regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
Requirements
Post‑Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant scientific discipline.
Strong knowledge of FDA and international regulatory requirements and guidelines.
Excellent communication, negotiation, and project management skills.
Ability to work effectively in a cross‑functional team environment.
Attention to detail, strong analytical skills, and problem‑solving abilities.
Adaptable and able to thrive in a fast‑paced, high‑growth environment.
If you think you're a good fit and looking for a new challenge, apply now.
#J-18808-Ljbffr