Amgen - Regulatory Affairs CMC Manager - SPPM (7-13 yrs)

Job Description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do:

Lets do this. Lets change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:

- Driving continuous improvement of processes and tools

- Ensuring awareness of processes across the organization; and

- Shaping the training strategy across the organization

The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes.

Job responsibilities of the SPPM Manager include:

- Support the new hire onboarding program

- Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness

- Drive consistency across Global CMC & Device Regulatory Affairs

- Develop and maintain training materials Global CMC & Device Regulatory Affairs

- Train staff on select departmental processes and procedures

- Ensure consistent use of processes and tools across department

- Continuous improvement of templates for presentations, timelines, trackers, and other tools

- Liaise with functions in GRAAS and Operations to ensure alignment

- Participate in cross-functional special project teams

- Potential to oversee or manage staff

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

- Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR

- Masters/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR

- Bachelors degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

Technical & Functional Expertise:

- Bachelors degree or higher in Life Sciences, Engineering, or a related field

- Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry

- Working knowledge of Regulatory CMC processes and global submission requirements

- Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs

- Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms)

- Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus

Collaboration & Communication Skills:

- Strong project management and organizational skills with the ability to manage multiple priorities

- Excellent written and verbal communication skills, with experience presenting to diverse audiences

- Demonstrated ability to collaborate across global, cross-functional, or matrixed teams

- Experience supporting onboarding, training, or continuous improvement initiatives

- Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency

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, well 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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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