Regulatory Affairs Manager (CMC)

Amgen Inc. (IR); Hyderabad; On-site; INR 2,800,000 - 3,800,000; Full time

Job summary

Amgen Inc. in Hyderabad is seeking an RA CMC Manager to lead global regulatory CMC activities, provide strategic direction, and coordinate with site and regional teams for successful submissions.

The role requires coordinating with regulatory and operations management, developing dossiers, and driving process improvements while aligning with external regulatory policy updates.

Qualifications

• CMC- specific regulatory knowledge & experience.
• Experience coordinating global regulatory submissions.
• Ability to lead cross-functional teams and communicate regulatory strategy.

Responsibilities

• Generate and execute global and country-specific regulatory strategies.
• Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements and submission strategy.
• Develop global dossiers for CMC content for initial submissions, variations and amendments.
• Support change management activities and respond to health authority questions.
• Liaise with development, operations and commercial to align timing and supply plans.
• Monitor tracking systems and ensure information is current in RIM.

Skills

Regulatory CMC knowledge

Leadership

Global regulatory strategy

Cross-functional collaboration

Regulatory risk assessment

Education

Doctorate degree

Master’s degree + 3 years experience

Bachelor’s degree + 5 years experience

Tools

RIM systems

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 .

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