Regulatory Affairs Manager

3 days ago

Hyderabad India Amgen Full time

Job Description 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. careers.amgen.com

  • Regulatory Affairs Specialist

    2 days ago

    Hyderabad, Telangana, India Morulaa HealthTech Pvt. Ltd. Full time

    Company DescriptionMorulaa HealthTech Pvt. Ltd. was founded to assist in the commercialization of bio-science technologies and the growth of healthcare companies. Based in Ohio and collaborating with Cleveland Clinic, University Hospitals, and Case Western Reserve University, Morulaa specializes in the Registration of Medical Devices and Distributor...

  • Regulatory Affairs Manager

    4 days ago

    Hyderabad, Telangana, India Evertogen Life Sciences Full time ₹ 80,00,000 - ₹ 1,50,00,000 per year

    We seek a seasoned Regulatory Affairs Head to lead and drive the global regulatory strategy for our formulation-based pharmaceutical products across Europe and Rest of World (ROW) markets at Evertogen Life Sciences. As the Regulatory Affairs Head, you will play a crucial role in overseeing all regulatory submissions, compliance management, and lifecycle...

  • Regulatory Affairs Specialist

    2 weeks ago

    India Concept Medical Full time

    About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...

  • Regulatory Affairs Manager I

    3 weeks ago

    Bengaluru, India AstraZeneca Full time

    Job Description Job Title: Regulatory Affairs Manager I Global Career Level: D1 Introduction To Role Are you ready to be part of a team that transforms drug development strategies into reality The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

  • Regulatory Affairs Associate Director

    3 days ago

    Hyderabad, India Amgen Full time

    Job Description 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 remains on the...

  • Regulatory Affairs

    1 week ago

    India, Maharashtra, Govandi USV Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    ear Candidate,We are seeking a Senior Executive/ Assistant - Regulatory affairs Europe)  to join our team, He/ she will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approvals. based at Govandi Location.Markets : EuropeDosage Form :  OSD/ SterileKey Responsibilities:● Collate/prepare and file dossiers in...

  • Executive Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Jodas Expoim Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job Title: Regulatory Affairs ExecutiveDepartment: Regulatory AffairsLocation: HyderabadExperience: 1-5 YearsIndustry: Pharmaceuticals (Injectables / OSD)About Jodas ExpoimJodas Expoim is a fast-growing, global pharmaceutical company committed to delivering high-quality, affordable medicines. We focus on complex injectables and are driven by innovation,...

  • Regulatory Affairs Executive

    1 week ago

    Hyderabad, Telangana, India Lorven Biologics Private Limited Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    We're Hiring – Regulatory Affairs ExecutiveAre you a regulatory professional looking to grow your career?We're looking for a Regulatory Affairs Executive with 2 years of experience to join our team.What you'll do: Prepare and review regulatory submissions and documentation Ensure compliance with national/international regulatory standards Coordinate with...

  • Regulatory Affairs Assistant

    1 day ago

    hyderabad, India Gamut HR Solutions Full time

    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 Executive

    2 days ago

    Hyderabad, India MakroCare Full time

    MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region...