Regulatory Compliance Change Assessor - Manager

Biopharma Careers; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Amgen in Hyderabad seeks an experienced Regulatory Change Assessor to join the Regulatory Compliance Team. You will interface with Global RA/CMC teams and Operations to shape regulatory strategies and assess global reportability for product changes.

The role requires leading regulatory activities, coaching junior staff, and driving process improvements within a cross-functional environment, ensuring compliance across divisions.

Qualifications

• Regulatory CMC knowledge & experience required
• Experience engaging with global RA/CMC teams
• Ability to define reporting and distribution restriction requirements
• Leadership and coaching of junior regulatory staff

Responsibilities

• Review change records for impact on reportability and product restrictions
• Define and document reporting requirements in the change control system
• Coordinate with Process Development, Operations, Quality and Supply Chain for regulatory alignment
• Provide regulatory expertise to cross-functional teams
• Coach and support junior regulatory staff’s career development
• Identify and implement process improvements in change management

Skills

Regulatory knowledge

Cross-functional collaboration

Leadership coaching

Education

Doctorate degree

Master’s degree with 4–6 years of regulatory/QA/QC/CMC experience

Bachelor’s degree with 6–8 years of regulatory experience

Diploma with 10–12 years of regulatory experience

Job description

Career Category

Regulatory

Job Description

Let’s do this. Let’s change the world. In this vital role you will report into the Regulatory Compliance Team lead.

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level.

Roles & Responsibilities

• Key responsibilities of the Regulatory Manager include:
• Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope.
• Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system.
• Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies
• Provides expertise and guidance to interdepartmental and cross-functional teams
• Coaches and support junior regulatory staff’s career development
• Identifies and implements process improvements for the change management process

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
• Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
• Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications

• Degree in Life Science discipline
• Regulatory CMC specific knowledge & experience
• Understanding and application of principles, concepts, theories and standards of scientific/technical field
• Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com.