Assistant Manager – Regulatory Affairs

3-6 years

Not Disclosed

Bengaluru

10 Feb. 16, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job ID: R-217891
Date Posted: 01/22/2025

Regulatory Affairs Specialist

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Position Purpose

Monitor and promptly report the status of all product licenses.
Implement submission plan for new products and product maintenance (license amendments, updates to registration files, etc.) as approved and deliver plans on time.
Collate, communicate, and prepare for health authorities’ queries.
Perform archival & update submission trackers.

Internal Customers:

Marketing, Sales, Logistics, Medical, Legal Affairs, Intellectual Property, Clinical Operations, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites, and QA, Regional Office.

External Customers:

CDSCO Office, NIB, IPC, CDTL, CDL, NCB & DCK, and other Local Health Authorities and Government Agencies.

Minimum Requirements

Education: M.Pharm/B.Pharm/M.Sc
Experience: 3-6 years in the India Regulatory function, with knowledge of dossier compilation.
Skills: Conversant with Indian regulations.

Key Result Areas / Outputs

Adherence to AstraZeneca and industry codes of conduct, ethics, and good regulatory practices.
Ensure all licensing for assigned products is completed per relevant norms.
Develop and implement regulatory plans for new products to achieve requisite approvals rapidly and facilitate a quick launch.
Evaluate the impact of new guidelines in liaison with RA leadership.
Support regulatory competitive intelligence and analysis.
Monitor the status of product licenses.
Project manage changes in product licenses and coordinate with other planned and in-progress changes.
Maintain complete documentation records and update all trackers timely.
Communicate license status changes promptly.
Maintain detailed knowledge of critical aspects of products, including commercial strategies, dossier content, regulatory intelligence, regulatory timelines, and supply strategy.
Implement regulatory strategy plans for new launches in conjunction with key stakeholders and deliver plans on time.
Track status and take corrective measures whenever necessary to ensure rapid approval and launch.
Ensure timely submission for regulatory compliance for commercial and clinical trials per external and internal norms with minimum supervision.
Support internal and external audits.
Support deviations/CAPA as needed.
Ensure timely submission of import registration/renewal and production transfer for business continuity.
Support artwork review and local FDA licenses as assigned.
Handle submission/review/query responses for global clinical trials/Phase IV/PMS studies, including SEC preparation.
Manage regulatory compliance during study conduct, including renewal/amendments and study closure with minimal supervision.

Why AstraZeneca?

At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference in medicine, patients, and society. We foster an inclusive culture that champions diversity, collaboration, and continuous learning. Join us on our exciting journey to pioneer the future of healthcare.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with a wide range of perspectives, and harnessing industry-leading skills. We comply with all applicable laws and regulations on non-discrimination in employment, as well as work authorization and employment eligibility verification requirements.

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