Sr. Associate Regulatory Affairs

3 days ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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. Amgens 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, postmarket 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:

  • Masters degree OR
  • Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • Associates degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR
  • High school diploma GED and 8 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

  • Regulatory Affairs Sr Associate

    3 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable...

  • Sr Associate Regulatory Affairs

    3 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams toOptimize product development and regulatory approvals in International countriesDevelop...

  • Regulatory Affairs Associate

    4 days ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Sr. Associate Regulatory Affairs Career CategoryRegulatory Job Description 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...

  • Sr Associate Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...

  • Sr Associate Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of...

  • Regulatory Affairs Associate Director

    3 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Role description:Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this...

  • Sr Mgr Regulatory Affairs

    3 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 10,00,000 - ₹ 25,00,000 per year

    Sr Manager - Gen Med Biosims International Regulatory LeadThe Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements.Group PurposeInternational Regulatory Affairs provides...

  • Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Clininfotech Full time ₹ 4,00,000 - ₹ 6,00,000 per year

    We are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...

  • Sr. Associate Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    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...

  • Regulatory Affairs Intelligence Sr Mgr

    3 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of...