Regulatory Affairs Manager

6 days ago

Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 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. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India. The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries.

The team member will be responsible for maintaining U.S. state and federal commercial product licenses and will collaborate with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams on strategies and activities impacting licensed products.

Roles & Responsibilities:

Key responsibilities of the Regulatory Affairs Manager include:

    • Conducts periodic assessments of licenses / facilities and ensures business practices comply with current regulations and statutes.

  • Evaluates new and existing regulations to maintain up-to-date compliance.

  • Communicates requirements to internal Amgen functional teams.

  • Obtains supplemental documentation from internal and external partners.

  • Prepares, reviews, and submits license applications and renewals.

  • Maintains all State Licensing documentation, submissions, and interactions with State Authorities.

  • Interfaces with State Board of Pharmacy (BoP) and/or Department of Health (DoH).

  • Completes required annual notifications to U.S. FDA

  • Obtains DUNS and FEI numbers for new U.S. sites, as required

  • Processes Financial obligations relating to fee payment.

  • Identifies and implements process improvements for the state licensing process

  • Coaches and supports junior regulatory staff's career development

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The successful candidate will have the following qualifications:

Basic Qualifications:

  • Doctorate degree OR
  • Master's degree and 3 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
  • Bachelor's degree and 5 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

  • Degree in Life Science discipline
  • Regulatory CMC specific knowledge & experience
  • Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
  • Working knowledge of US state and/or federal licensing requirements
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, we'll 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.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

  • Regulatory Affairs

    7 days 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...

  • Regulatory Affairs Manager

    4 days ago

    Hyderabad, Telangana, India Revio Therapeutics Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Role DescriptionRevio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have...

  • Regulatory Affairs CMC

    7 days ago

    Hyderabad, Telangana, India Vipsa Talent Solutions Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Regulatory Affairs CMCExperience: 6-11 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, US market, CMC

  • Regulatory Affairs Associate

    5 days ago

    Hyderabad, Telangana, India Vipsa Talent Solutions Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Regulatory Affairs AssociateExperience: 3-6 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval

  • Regulatory Affairs

    7 days ago

    Hyderabad, Telangana, India Biological E Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Regulatory Affairs Job OpportunityDesired Experience : 3- 9 yearsJob Location : Genome Valley, Shameerpet, HyderabadPreferred Industry : Vaccines / BiotechDesignation: Senior Executive/ ExecutiveQualification: M. Pharmacy/ M. Sc/ B. PharmacyJob Responsibilities:Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World...

  • Regulatory Affairs CMC Associate

    4 weeks ago

    Hyderabad, Telangana, India Ztek Consulting Full time

    Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...

  • Regulatory Affairs Assistant

    7 days ago

    Hyderabad, Telangana, India Gamut HR Solutions Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Company OverviewGamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at Job OverviewWe are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in...

  • Regulatory Affairs Officer

    2 weeks ago

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

    This role is for one of the Weekday's clientsSalary range: Rs Rs ie INR LPA)Min Experience: 3 yearsLocation: HyderabadJobType: full-timeWe are seeking a detail-oriented Regulatory Affairs Officer with 2–8 years of experience to join our team in Hyderabad, Nacharam. The ideal candidate will have expertise in Drug Master Files (DMF), ICH guidelines, and...

  • Regulatory Affairs CMC Associate

    3 weeks ago

    Hyderabad, Telangana, India Ztek Consulting Full time

    Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...

  • Regulatory Affairs- eCTD Specialist

    4 days ago

    Hyderabad, Telangana, India Nooha Asp Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Regulatory Affairs Hiring Profile eCTD SpecialistExperience Level: 3 to 6 YearsLocation: Work from office (Hyderabad)Skills & Qualifications:1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field.2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the...