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Amgen Sr. Associate Regulatory Affairs Job in Hyderabad
Amgen has an opportunity for a Sr. Associate Regulatory Affairs professional in Hyderabad, Telangana. The position focuses on Chemistry, Manufacturing and Controls (CMC) regulatory submissions, technical documentation and coordination with global teams.
Candidates with a bachelor’s degree and 5–9 years of relevant industry experience may be eligible. If you are preparing for Regulatory Affairs interviews, you can also practice with our free Regulatory Affairs (RA) Mock Test with Certificate.
1. Amgen Job Details
| Job Information | Details |
|---|---|
| Company | Amgen |
| Position | Sr. Associate Regulatory Affairs |
| Job ID | R-250844 (as provided in the job description) |
| Department | Regulatory Affairs – CMC |
| Location | Hyderabad, Telangana, India |
| Work arrangement | On-site |
| Qualification | Bachelor’s degree |
| Experience | 5–9 years |
| Application mode | Online |
| Official job listing | View Job & Apply |
| Other vacancies | Search Amgen Careers |
Check the official listing to confirm the job identifier and whether applications are still open.
2. About the Role
Regulatory Affairs CMC professionals help ensure that pharmaceutical and biotechnology products have the technical documentation required for regulatory review and approval.
CMC stands for Chemistry, Manufacturing and Controls. It covers information about a product’s composition, manufacturing process, quality specifications, testing and stability.
In this role, the selected candidate will coordinate regulatory documents, support submissions across different markets and work with global regulatory, manufacturing and quality teams.
3. Eligibility Criteria
| Requirement | Details |
|---|---|
| Education | Bachelor’s degree |
| Experience | 5–9 years |
| Relevant fields | Pharmaceutical or biotechnology manufacturing, QA/QC or regulatory CMC |
| Preferred education | Life sciences degree |
| Additional preferred experience | Process development, analytical development, IVD, medical devices or combination products |
| Technical skills | Regulatory documentation and familiarity with Veeva Vault |
| Other skills | Communication, organization and project management |
Applicants should meet the basic qualifications and review the full job description before applying.
4. Roles and Responsibilities
The role involves preparing and coordinating regulatory submissions and ensuring that supporting documents are organized and delivered on time.
| Work area | Key responsibilities |
|---|---|
| Regulatory submissions | Coordinate CMC and device-related submission documents |
| Reports and renewals | Support annual reports, facility registrations and product renewals |
| Submission planning | Prepare content plans for applications, amendments and variations |
| Document management | Maintain regulatory records and archive submission communications |
| Project coordination | Track timelines and report progress to relevant teams |
| Cross-functional collaboration | Work with authors, reviewers, subject-matter experts and regulatory operations |
| Team support | Contribute to special projects and train colleagues on selected procedures |
5. Skills to Prepare for Regulatory Affairs Roles
Candidates interested in similar positions should understand the following areas.
| Skill or topic | Why it matters |
|---|---|
| ICH quality guidelines | Helps with understanding pharmaceutical development and quality systems |
| Common Technical Document (CTD) | Provides a standard structure for regulatory submissions |
| CTD Module 3 | Covers quality-related information about drug substances and drug products |
| GMP documentation | Supports compliance with manufacturing and quality requirements |
| Change control and CAPA | Helps manage changes and investigate quality issues |
| Regulatory lifecycle management | Covers variations, renewals and post-approval changes |
| Document management systems | Supports document control, review and submission tracking |
Relevant experience is particularly important for this experienced-level position. Candidates should describe their actual responsibilities rather than listing skills they have not used.
6. How to Apply
Follow these steps to apply through Amgen’s official careers website:
- Open the official Amgen job listing.
- Check the eligibility criteria and complete job description.
- Click Apply Now, if the vacancy is open.
- Sign in or create an account if required.
- Complete the application and upload your updated resume.
- Review your details and submit the application.
Resume tips
Before applying, make sure your resume clearly shows:
- Your relevant industry experience.
- Regulatory submissions or documentation you have supported.
- Your experience in manufacturing, QA, QC or regulatory CMC.
- Your knowledge of applicable systems, including Veeva Vault if relevant.
- Examples of project coordination and cross-functional work.
Keep your experience accurate and specific to your actual responsibilities.
Apply here: Amgen Sr. Associate Regulatory Affairs – Hyderabad
7. Search for Other Amgen Jobs
If this role does not match your experience, you can look for other openings on the company’s careers website.
Try searching by job title, department or location using terms such as:
- Regulatory Affairs
- Regulatory CMC
- Regulatory Operations
- Quality Assurance
- Quality Control
- Manufacturing
Check each listing separately because qualifications, experience requirements and application status vary.
8. Regulatory Affairs Career Resources
Explore these resources from Pharma Career Updates to learn more about the field and prepare for related opportunities.
| Resource | What you will find |
|---|---|
| Regulatory Affairs Mock Test with Certificate | 50 multiple-choice questions to practice regulatory concepts |
| Career in Regulatory Affairs After B.Pharm | Career pathways, job roles and relevant skills |
| Latest Regulatory Affairs Jobs | More RA job opportunities |
| WhatsApp Channel | Pharmaceutical job updates |
| Telegram Channel | Pharma career information and updates |
9. Frequently Asked Questions
9.1 Where is the Amgen job located?
The position is listed in Hyderabad, Telangana, India, with an on-site work arrangement.
9.2 What qualification is required?
A bachelor’s degree is required. A degree in life sciences is preferred.
9.3 How much experience is required?
The stated requirement is 5–9 years in pharmaceutical or biotechnology manufacturing, QA/QC or regulatory CMC.
9.4 Can freshers apply?
This position is intended for experienced professionals. Freshers without the required industry experience are unlikely to meet the basic criteria.
9.5 Is QA or QC experience relevant?
Yes. QA/QC experience is included in the stated experience criteria, although candidates must meet all other requirements as well.
9.6 How can I find other Amgen vacancies?
Visit the official Amgen Careers portal and search by job title, department or location.
Disclaimer: Pharma Career Updates is an independent job-information platform and is not affiliated with or endorsed by Amgen. Details are based on the supplied job description and may change. Candidates should confirm the job identifier, vacancy status, eligibility and application instructions on Amgen’s official website before applying.
