Great opportunity for Senior Associate Regulatory Affairs at Amgen – Life Sciences, Pharmacy Apply


Website Amgen

About Amgen

For over 40 years, Amgen has been at the forefront of biotechnology advancements, bridging the gap between laboratory discoveries and patient care. The company’s dedication to developing groundbreaking human therapeutics is complemented by its investment in advanced manufacturing capabilities and comprehensive support services. This commitment enables Amgen to efficiently deliver these innovative treatments to medical professionals worldwide. Notably, the Japan and Asia Pacific (JAPAC) region stands out as the fastest-growing area for Amgen, underscoring the company’s global impact and its commitment to improving healthcare outcomes.

Post: Sr. Associate Regulatory Affairs

Job Description :

As a Local Regulatory Representative (Sr. Associate), you will be assigned to specific Amgen products and may either support a LRR or lead a program under the guidance of an experienced Local Regulatory Lead. The products you work on will have medium complexity programs/strategies and a moderate impact on Amgen.

Main Responsibilities:

  • Align Local Regulatory Requirements: Assist in aligning local regulatory requirements with Amgen’s corporate standards.
  • Filing Plan Contribution: Contribute to the filing plan (Marketing Authorization and Lifecycle maintenance) by advising and collaborating with the local cross-functional team. With close supervision, implement the filing plan for the country(ies) when applicable.
  • Regulatory Strategy Implementation: Provide country-specific or regional input and implement regulatory strategies.
  • Lead Local Regulatory Submissions: Plan and lead local regulatory submissions in adherence to corporate standards and local regulations.
  • Optimize Product Development: Offer guidance on local mechanisms to optimize product development and regulatory approvals.
  • Local Label Maintenance: Ensure local labels align with local laws, Amgen standards, and procedures.
  • Regulatory Agency Liaison: Act as the primary contact with regulatory agencies.

Candidate Profile

  • Qualifications: Hold a degree in Life Sciences, Pharmacy, or a Biomedical field with 3-5 years of relevant regulatory experience.
  • Regulatory Knowledge: Possess knowledge of Regulatory principles.
  • Policy and Procedure Familiarity: Have experience working with policies, procedures, and SOP’s.
  • Comprehensive Regulatory Understanding: Understand regulatory activities and their impact on other projects and processes.
  • Indian Regulations Expertise: Possess good knowledge of Indian regulations concerning new product registration, lifecycle management, clinical trials, and SUGAM portal handling.
  • Registration Procedures Awareness: Exhibit general awareness of registration procedures and challenges in the country(ies) for Clinical Trial Applications (CTAs), Marketing Authorizations (MAs), and all lifecycle management activities.
  • Country-specific Regulatory Environment: Have knowledge and experience in the regulatory environment of the country(ies) relevant to the product area and development stage.
  • Drug Development Understanding: Demonstrate an understanding of drug development.

Additional Information

  • Experience: 3-5 years
  • Qualification: Degree in Life Sciences, Pharmacy
  • Location: Mumbai, India
  • Industry Type: Pharma / Healthcare / Clinical research
  • Functional Area: Regulatory Affairs
  • End Date: 10th September 2023

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