About Company
AMGEN INC is an international Biotechnology company and one of the biggest independent biotech companies in the world it was founded in 1980, and headquartered in California, Amgen deals in discovering, developing, manufacturing, and delivering innovative human therapeutics including oncology, cardiovascular disease, neuroscience, inflammation, and bone health. For more details about the company please visit Amgen
AMGEN INC is hiring fresher Pharma candidates for the Senior Associate Regulatory Affairs post. All details related to the job are mentioned below.
Amgen Biotech Vacancy Details
- DESIGNATION – Senior Associate RA
- DEPARTMENT – Regulatory Affairs
- DIVISION – Regulatory
Job Description
- Planning, drafting, accumulation, and certification of country-specific CMC documents.
- Handle the submission process for annual reports, facility registration, renewing facility licenses, and product renewals.
- Preparing submission content roadmaps for CMC submissions, such as CMS IND/CTAs amendments, new marketing applications, product renewals, module 3 baselines, facility registration, and annual reports.
- Update teams and departmental groups on the status of activities and project deadlines.
- Capture and store CMC submissions and relevant communications in the document management system.
- Coordinate with authors, subject matter experts, and reviewers to ensure the timely completion of CMC documents for regulatory submission.
- Develop and monitor CMC product deadlines based on the product lead’s instructions.
Eligibility Criteria
- Candidates must have a Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm)
- Bachelor’s degree in Life Sciences
- Minimum 01 years of experience is required in production, QA/QC, or regulatory CMC in Biotech or Pharma
- Proven Project management and organizational expertise
- Good Knowledge of Veeva Vault software
- Excellent Verbal and Oral Communication skills
Salary & Other Details
- The Salary may vary between INR 3,00,000 to INR 6,00,000 per annum (Estimated Salary)
- Job Location – Hyderabad, Telangana, India,
- Contract Type – Full-Time
- Work Mode – Onsite
- Industry Type – Biotechnology Company
Disclaimer: The salary figure mentioned is estimated from different websites like Glassdoor, AmbitionBox, etc.
Required Documents
- Educational Qualification Documents.
- CTC Slip
- Aadhar Card / PAN Card
- Appointment Letter
How to apply?
- Candidates may apply for the post by filling out an application form using the given Link.
Application Link: Click Here
- Shortlisted Candidates will receive the mail from the HR department for the interview.
