AMGEN INC is an international Biotechnology company and one of the biggest independent biotech companies in the world. It was founded in 1980 and is headquartered in California. Amgen combines deep scientific innovation with robust manufacturing and a broad drug pipeline, maintaining a leadership role in biotech. For more details about the company, please visit Amgen
Key Role Information
AMGEN INC is looking for freshers and experienced Pharma / Life Science / Biotech graduates for the job role of Associate Regulatory Writer, and the person will be working at Amgen’s Hyderabad-based office. All details related to the job role are mentioned below.
- DESIGNATION – Associate Regulatory Writing
- DEPARTMENT – Regulatory Affairs
- DIVISION – Clinical Trial Disclosure
- EXPERIENCE – Freshers & Experienced
Job Responsibilities
- Draft clinical regulatory documents for public disclosure.
- Ensure Compliance with regulatory requirements and the agreed cross-functional plan.
- Accountable for maintaining consistency in quality and ensuring submission readiness, and ensuring the timely submission of documents.
- Collaborate with a cross-functional department to facilitate the delivery of work within the specified time.
- Assist in trial disclosure audits and inspections.
- Coordinate with the team members to find a resolution and fix issues when required.
- Act as Operational Supporter for CTRS, supporting users, system access, and issue resolution.
- Ensure Anonymization of personal data and Redaction of commercially confidential information.
- Follow all the company’s internal policies, established procedures, guidelines, standard operating procedures (SOPs), and training materials.
Education Qualification
- Bachelor’s degree in Pharmacy (B.Pharm)
- Bachelor’s degree in Life Sciences, Clinical Research, Regulatory Affairs, and Biotechnology (B.Sc / B.Tech)
- Minimum 01 year of working experience with regulatory documents in any biotech or pharmaceutical company/
Skills Required
- Familiar with NIH Protocol Registration System (PRS)
- Good at working Clinical Trial Registry System (CTRS)
- Deep understanding of EU CTIS and other registries
- Basic knowledge of regulatory procedures and filings
- Good Verbal and Oral Communication skills.
Regulatory Affairs Associate Salary & Other Details
The Salary may vary between INR 3,00,000 to INR 6,00,000 per annum (Estimated Salary)
Nature of Employment
- Job Location – Hyderabad, Telangana, India,
- Contract Type – Full-Time
- Work Mode – Onsite
- Industry Type – Biotechnology Company
How to apply for the Regulatory Affairs Job at Amgen Biotech?
Candidates may apply for the post of Associate Regulatory Writer by filling out an application form using the given Link. Fill in all the details carefully with accurate data, and upload your updated resume that contains accurate educational qualifications and experience. Shortlisted Candidates will receive an email from the HR department for the interview.
