[Skip to main content](#main-content)

[OpenNash Jobs](https://jobs.opennash.com/)
[Hiring report](/reports/hiring/) · [All Amgen jobs](https://jobs.opennash.com/companies/amgen/) · [Search jobs](/search/)

Amgen · India - Hyderabad

# Regulatory Affairs Manager (CMC)

India - Hyderabad Manager or lead Legal & Compliance 

Listed on Amgen’s official careers site. Listed as of October 18, 2026. Check that it is still open and apply there.
[Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/India---Hyderabad/Regulatory-Affairs-Manager--CMC-_R-224460)

[OpenNash Jobs](https://jobs.opennash.com/) / [Amgen](https://jobs.opennash.com/companies/amgen/) / Regulatory Affairs Manager (CMC)

## Job description

Career Category Regulatory

### Job Description

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management.

The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal

Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.

### Key Responsibilities

Include:
- Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
- Develop global dossiers for CMC content for initial submissions, variations and amendments
- Support change management activities
- Develop response strategy and respond to health authority questions
- Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
- Liaise with local regulatory teams to align on filing strategy
- Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current.
- Maintain submission information according to the Regulatory Information Management (RIM) system
- Follow established department regulatory processes to ensure cross-product alignment
- Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience.

## At a glance
- Posted by the employer: Not stated
- First seen by OpenNash: Jul 10, 2026
- Last checked: Oct 18, 2026
- Listed for: 100 days
- Location: India - Hyderabad[Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/India---Hyderabad/Regulatory-Affairs-Manager--CMC-_R-224460)

## More jobs at Amgen

### [Global Regulatory Writing Manager](https://jobs.opennash.com/companies/amgen/jobs/33aa8d1c63153bf19edf/)

India - Hyderabad

### [Global Regulatory Writing – Senior Associate](https://jobs.opennash.com/companies/amgen/jobs/da2cb05cf4a7ceaea0d8/)

India - Hyderabad

### [Manager - International Regulatory Lead](https://jobs.opennash.com/companies/amgen/jobs/f0ce9f43b534cab2b328/)

India - Hyderabad

### [Manager Supply Chain Compliance](https://jobs.opennash.com/companies/amgen/jobs/b2d225191e89ad617a13/)

India - Hyderabad

### [Regulatory Affairs Mgr](https://jobs.opennash.com/companies/amgen/jobs/f4bcf7840369f64cfc61/)

India - Hyderabad

## Similar jobs at other companies

### [FSP Regulatory Affairs Specialist - CMC Compliance Officer client dedicated](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/d6fbee4c19062e62ecf3/)

Thermo Fisher Scientific · Remote, Belgium

### [Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/525d84d2e7a6f0989e79/)

Thermo Fisher Scientific · Remote, Switzerland

### [[Innovative Medicine] R＆D, Scientist, CMC Group, CMC Sciences, Regulatory Affairs](https://jobs.opennash.com/companies/johnson-johnson/jobs/574b08a6e494e96481d9/)

Johnson & Johnson · Chiyoda, Tokyo, Japan

### [[Innovative Medicine] R＆D, Principal Scientist, CMC Group, CMC Sciences, Regulatory Affairs](https://jobs.opennash.com/companies/johnson-johnson/jobs/3503f789f40ca82d0a05/)

Johnson & Johnson · Chiyoda, Tokyo, Japan

### [Associate Director, Regulatory Affairs, CMC- Biologics](https://jobs.opennash.com/companies/alnylam-pharmaceuticals/jobs/eedf15801e22c49f813b/)

Alnylam Pharmaceuticals · Cambridge

OpenNash lists jobs from employers’ own careers sites and does not handle applications.
Dates come from the employer where stated; “first seen” and “last checked” are our own observations.

OpenNash Jobs · Official listings with dates and links to the employer. [Weekly hiring report](/reports/hiring/) · [Methodology](/methodology/)