Lead - Regulatory Affairs

Lead Regulatory Affairs

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.

Marketing Company Regulatory Lead 

Job Description :

• Lead regulatory affairs for assigned 1/more franchise from clinical development up to life cycle maintenance 

• Prepare regulatory strategies including risk mitigation plans for accelerated regulatory approvals of new products, clinical trials and ensure flawless implementation of regulatory strategies and drive SEC preparedness along with medical. 

• In-depth knowledge of global/ local clinical trials and proactively efforts for India inclusion in global trials 

• Ensure ~100% regulatory compliance as per internal and external expectations including post approval commitments, labelling, site transfers, biologicals.  

• In-depth knowledge of Indian regulations essential and regulatory expertise in innovative treament modalities is desirable  

• Ensure cross-functional collaboration locally (business, QA, medical, supply etc) and with International RA to ensure alignment of regulatory activities  

• Act as GRP lead and perform periodic reviews of RA function as per GRP Quality management systems.  

• Earlier initiatives of regulatory policy shaping and Health Authority advocacy efforts is necessary 

• Ensure 100% regulatory compliance for assigned franchise 

• Experience of earlier people management responsibility 

Core Accountabilities 

The MC Regulatory Lead is responsible for: 

• For assigned Franchise, accelerating approvals of innovative new products, additional indications and global clinical trials as per priorities and drive impactful SEC preparedness 

• Act as lead for internal/ external audits if any for RA relevant areas, ensures deviations and CAPAs in place 

• Ensuring the GRP areas under their responsibility are run in accordance with external regulations.  

• As GRP Lead, ensure that AZ's Good Regulatory Practices initiatives are implemented and comply with the planning established including: 

• Ensure the training of the regulatory team for new procedures as well as updates on the current procedures. 

• Active contribution in Industry association for regulatory policy advocacy efforts 

• Cross functional collaboration and alignment across local teams as well as with International Regulatory affairs teams 

• Ensures assessment of new regulatory guidance and impact assessment, implementation 

• Regulatory support to Business Development projects 

• Oversight of regulatory intelligence 

• Reviews people development needs, closely monitors initiatives as needed 

Typical People Management Responsibility (direct/ indirect reports) – 3 to 4, approximate number of people managed in total (all levels)

Education, Qualifications, Skills and Experience 

Essential 

• Pharmacy graduate 

• People management experience 

Desirable 

• Post-graduate qualification in Pharmacy 

• Experience in regulatory affairs, drug development, clinical trials preferred 

• Regulatory expertise in newer treatment modalities 

Key Relationships to reach solutions : (External to AZ)

Industry Regulatory Bodies

Why AstraZeneca? At AstraZeneca we’re 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 to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

Date Posted

18-Mar-2026

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Experience Level

Senior Level