Are you passionate about advancing the biotechnology industry? Amgen, a globally renowned human therapeutics company, is seeking a Sr. Associate – Regulatory Affairs to join their team in Hyderabad, India. This role offers the chance to contribute to innovative medical practices and play a vital part in Amgen’s mission to fight serious illnesses through cutting-edge solutions.
About Amgen: A Leader in Biotechnology
Amgen has been a pioneer in biotechnology for over 40 years. As a Fortune 500 company, Amgen combines scientific discovery with innovation to improve lives worldwide. Focused on advancing medicine, Amgen fosters a science-driven culture that inspires solutions for challenging health issues.
Job Responsibilities
As part of the Regulatory Affairs, Chemistry, Manufacturing, and Controls (RA CMC) team, the Sr. Associate will support product development, regulatory strategies, and global submissions for manufacturing and quality programs. Specific responsibilities include:
- Leading submissions for annual reports, facility registrations, renewals, and product updates.
- Collaborating with authors, reviewers, and subject matter experts for CMC document delivery.
- Preparing submission content plans for various CMC regulatory submissions.
- Coordinating and legalizing country-specific CMC documents.
- Managing and archiving CMC submissions and related communications in document management systems.
- Maintaining CMC product timelines in alignment with project goals.
- Interfacing with the regulatory operations team for seamless workflow.
- Training staff on CMC procedures and systems.
- Participating in cross-functional special project teams.
Required Qualifications
To excel in this role, candidates must meet the following requirements:
- Master’s Degree or
- Bachelor’s Degree with 1-2 years of experience in manufacturing, QA/QC, or regulatory CMC within the pharmaceutical/biotechnology industry.
- Associate’s Degree with 6 years of relevant experience.
- High school diploma or GED with 8 years of relevant experience.
Preferred Qualifications and Skills
Ideal candidates will bring:
- A Bachelor’s Degree in Life Sciences.
- Proven experience in manufacturing, process development, quality assurance, or analytical development.
- Knowledge of regulatory CMC processes and best practices.
- Advanced project management and organizational abilities.
- Strong communication skills, both oral and written.
- Familiarity with Veeva Vault platforms for document management.
