Jeedimetla Hyderabad Telangana Quality control qc Jobs – 94 Open Jobs Today

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Tax Manager, Transfer Pricing

Amgen -
Hyderabad, Telangana

Apply Now

Job details

Qualifications

B.Sc
Biotechnology
Project management
Quality assurance
Bachelor's degree
Quality control
QA/QC
Document management systems
Communication skills

Full job description

India - Hyderabad

JOB ID: R-250844 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Aug. 31, 2026 CATEGORY: Regulatory

Job Description:

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries.

The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level.

Additional job responsibilities include:

Lead submission for annual reports, facility registrations, facility renewals, and product renewals
Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions
Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post‑market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications
Coordination, preparation, collection and/or legalization of CMC country specific documents
Document and archive CMC submissions and related communications in the document management system
Initiate and maintain CMC product and/or Device timelines at the direction of product lead
Interface with the regulatory operations team
Train staff on select procedures and systems
Provide report status of activities and projects to teams and department
Participate in cross-functional special project teams

Basic Qualifications:

Bachelor’s degree and 5-9 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

BS degree in Life Science
Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
Experience in IVD, Device or Combination Product regulatory submission process
Regulatory CMC specific knowledge and experience
Mature project management and organizational skills
Strong and effective oral and written communication skills
Experience in Veeva Vault platforms

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quality control qc jobs in jeedimetla hyderabad telangana

Tax Manager, Transfer Pricing

Architect Designer

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Neural Nexus – Data Steward, Data & AI Enablement (AuRA)

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