Regulatory Compliance Change Assessor - Manager

Amgen Inc. (IR); Hyderabad; On-site; INR 1,500,000 - 2,600,000; Full time

Job summary

Amgen Inc. (IR) in Hyderabad is seeking a Regulatory Compliance Change Assessor. You will interface with Global, Site, Biosimilars, and Device RA CMC teams to assess reportability and actions that impact products.

You will liaise with Operations, Quality and Supply Chain, provide guidance across teams, and coach junior staff while driving process improvements in change management.

Qualifications

• Doctorate or Masters with 4–6 years in pharma QA/QC or regulatory CMC.
• Bachelor’s with 6–8 years in pharma QA/QC or regulatory CMC.
• Diploma with 10–12 years in pharma QA/QC or regulatory CMC.

Responsibilities

• Reviews change records to evaluate impact on reportability and product restrictions.
• Defines and documents reporting and distribution restriction requirements.
• Liaises with Process Development, Operations, Quality and Supply Chain.
• Provides expertise to interdepartmental and cross-functional teams.
• Coaches junior regulatory staff and supports career development.
• Identifies and implements process improvements for change management.

Skills

Regulatory CMC knowledge

QA/QC experience

Process improvement

Education

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

Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Tools

Change control management system

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
• Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
• 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.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen