Assistant Manager – Regulatory Affairs Jobs at AstraZeneca careers: Grow Your RA Career in Mumbai
Kickstart your global regulatory career with AstraZeneca careers, where innovation meets purpose. This Assistant Manager – Regulatory Affairs role offers a dynamic opportunity for professionals passionate about shaping regulatory strategy and driving high-quality submissions. Ideal for those exploring advanced regulatory affairs jobs, this position empowers you to work on critical product approvals, compliance, and life-cycle management while contributing to AstraZeneca’s mission of transforming patient outcomes.
Job Details:
- Job Title: Assistant Manager – Regulatory Affairs
- Location: Mumbai, Maharashtra, India
- Job ID: R-240790
About The Company:
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.
Job Description | AstraZeneca Careers :
For assigned products: Regulatory strategy for NCE, Acceleration process Plan to gain rapid and high-quality approvals and ensure high standard of regulatory compliance, SEC Preparation, in order to achieve the company’s business objectives. Developing India specific Artwork, Support to Regulatory dossier preparation and Submission like New drug application, Site registration and Import licence. Managing Registration sample right from dispatch of samples till the report. As part of new drug application, ADC sample testing. Also, follow up for reports, License Life cycle management; Preparation & submission of PSURs.
Key Responsibilities | Regulatory Affairs Jobs:
Core Accountabilities & Key Result Areas
- Adherence to AZ and industry codes of conduct, ethics and good regulatory practices.
- Ensure that all licensing activities for assigned products are completed in compliance with all applicable regulations and standards.
- Develop and implement regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch.
- Assist in Issue Management.
- Maintain awareness of, and shape, the regulatory environment relevant to the assigned products.
- Conduct competitive intelligence and analysis.
Compliance & Conduct
- Align with the values and vision of AZ.
- Ensure compliance with local legislation, global regulatory policies, AZ code of conduct, corporate governance and audit requirements.
- Maintain company confidentiality including intellectual property, product information, and strategic data.
- Disclose potential breaches of codes or conduct.
License Management
- Monitor status of product licenses.
- Manage changes in product licenses and plan submissions and approvals.
- Maintain complete documentation records.
- Communicate license status changes promptly.
Regulatory Strategy Implementation
- Maintain detailed knowledge of critical aspects of products: commercial strategies, dossier content, regulatory intelligence, timelines, and supply strategy.
- Ensure local regulatory strategies align with global product strategies and priorities.
- Develop regulatory plans with key stakeholders.
- Track status and take corrective measures for rapid approvals.
- Strive for high levels of performance and accountability.
Issue Management
- Provide detailed regulatory status information of affected products.
- Follow up actions as necessary.
Regulatory Environment & External Relations
- Interact with regulatory authorities for necessary approvals/permissions.
- Monitor external regulatory and political changes impacting assigned products.
- Communicate impact to key stakeholders.
- Build strong collaborations with regulatory authorities.
Competitive Intelligence and Analysis
- Monitor global pipelines of competing pharmaceutical companies.
- Analyze information for impact on AstraZeneca research pipelines.
- Provide scenarios with options and risk–benefit assessment.
Management of India PSUR Submission
- Maintain PSUR Calendar.
- Prepare India-specific PSURs based on global PBRER.
- Submit within required timelines.
- Respond to Health Authority queries.
Global Clinical Trial Submissions
- Handle submissions/reviews/query responses for global clinical trials/Phase IV/PMS studies including SEC preparation.
- Manage renewal/amendments and ensure regulatory compliance till study closure.
- Maintain documentation records and trackers.
Qualifications Required For Regulatory Affairs Jobs:
Essential
- M.Pharm/B.Pharm 3-6yrs relevant Experience in India Regulatory function, knowledge of dossier compilation and review.
- Should be conversant with Indian regulations.
Desirable
- Knowledge of dossier compilation.
- Conversant with Indian regulations related to new drugs and clinical trials.
