Sr. Associate Regulatory Affairs

4 days ago


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

  • Master's degree OR
  • Bachelor's degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • Associate's degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry 
    OR 
  • 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
.

  • Hyderabad, Telangana, India Amgen Full time US$ 80,000 - US$ 1,20,000 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...


  • Hyderabad, Telangana, India Lifelancer Full time

    Job Title Sr Regulatory Affairs Specialist - ET-HyderabadJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose ...


  • Hyderabad, Telangana, India Thepharmadaily Full time

    Job Description- Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations- Support the Global Operating Unit Regulatory Affairs function as the local representative, ensuring requirements are met- Provide regulatory support for research and development activities and ensure compliance with Indian and...


  • Hyderabad, Telangana, India beBeeregulatory Full time ₹ 18,00,000 - ₹ 24,00,000

    Regulatory Affairs Senior AssociateWe are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Associate. This role will involve assisting in the development and implementation of regulatory strategies across all product brands.Preparation, tracking, reporting, and archiving US regulatory documentationManagement of Ad Promo...


  • Hyderabad, Telangana, India beBeeRegulatory Full time US$ 1,54,000 - US$ 2,41,300

    Regulatory Affairs ExpertThe Regulatory Affairs Manager is responsible for leading the execution and coordination of global regulatory activities.Key Responsibilities:Develop and execute strategic plans for global and country-specific regulatory complianceProvide CMC regulatory strategy by defining filing requirements, submission strategies, and risk...


  • Hyderabad, Telangana, India Lifelancer Full time

    Job Title Regulatory Affairs Specialist IIJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Senior Regulatory Specialist Job DescriptionThis role involves leading the preparation and submission of FDA 510(k) premarket notifications for medical devices. You will be responsible for preparing and reviewing regulatory documentation to ensure compliance with FDA regulations and standards.Key Responsibilities:Develop strategic plans for regulatory...


  • Hyderabad, Telangana, India Novartis Full time

    Job Description Summary The Senior Regulatory Coordinator (Sr. RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments.To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC,...


  • Hyderabad, Telangana, India Novartis Full time

    Job Description SummaryThe Senior Regulatory Coordinator (Sr. RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments.To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC, Regional...


  • Hyderabad, Telangana, India Amgen Full time

    Career Category Regulatory ABOUT AMGEN Amgen 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...