Regulatory Affair Manager

Regulatory Affairs Manager - Mumbai

About AstraZeneca

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

• Lead or participate as an expert regulatory member of cross-functional teams to provide strategic advice and operational support throughout the regulatory process, including product development, registration, launch, lifecycle management, and post-marketing activities.

• Plan, manage, and deliver complex global and/or regional regulatory submissions, briefing materials, responses to health authorities, and required documentation for all types of applications and maintenance activities.

• Advise senior management, product development teams, and business partners on regulatory strategies, project risks, timelines, and compliance requirements, ensuring that all commitments are clearly communicated and met.

• Drive continuous improvement in submission preparation and delivery processes, including electronic and paper publishing, documentation quality, and compliance with both local and global regulatory standards and AZ policies.

• Identify complex regulatory risks, propose and implement mitigation strategies, and ensure operational and strategic challenges are efficiently addressed.

• Build and maintains effective partnerships and communication channels with internal partners across functions (including Regulatory, R&D, Operations, Marketing, Manufacturing) as well as external partners such as health authorities, industry consortia, and vendors.

• Ensure that department systems and records accurately reflect regulatory statuses and submissions, promoting strong compliance with internal standards and external regulatory expectations.

• Coach and mentor colleagues, share regulatory expertise, and help develop the skills and capabilities within the team to cultivate a culture of courageous leadership, collaboration, and high performance.

• Keep abreast of changing worldwide health authority requirements, interpret and communicate regulatory intelligence, and drive the adoption of new requirements and standards into business processes.

• Champion the development and implementation of new regulatory systems, technologies, and strategies to strengthen AstraZeneca’s regulatory operations and maintain industry leadership.

• Essential: Proven 10-12 years of experience in regulatory affairs or drug development within the pharmaceutical or related industry; Detailed knowledge of the global/regional drug regulatory approval process, submission standards, and health authority requirements; Proven project management and leadership skills, including experience working with cross-functional and international teams; Strong communication, negotiation, and collaborative working abilities; Expertise in information and document management technology, including electronic and paper submission tools; Ability to identify, manage, and mitigate regulatory and operational risks

• Desirable: Experience in line or matrix management; Experience managing resource requirements for pivotal projects; Knowledge of AstraZeneca’s business, processes, and regulatory systems; Deep understanding of the current regulatory environment and evolving industry trend.

Date Posted

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.