Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen.
Post : Sr. Associate Regulatory Affairs
Job Description
The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support a LRR or lead a program under the supervision of an experience Local Regulatory Lead. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.
Main Responsibilities :
• Assist in aligning local regulatory requirements with Amgen’s corporate standards.
• Contribute for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team. With close supervision, implementing the filing plan (MA and Lifecycle maintenance) for the country(ies), where applicable.
• Provide country specific / regional (as applicable) input to and implement regulatory strategies.
• Plan and lead local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Act as the point of contact with regulatory agencies.
Candidate Profile
• Degree in Life Sciences, Pharmacy or Biomedical field and 3-5 years of relevant regulatory experience
• Knowledge of Regulatory principles.
• Working with policies, procedures, and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• Good knowledge of Indian regulations on new product registration, lifecycle management and clinical trials, SUGAM portal handling.
• General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
• Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
• 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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