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.

Accountabilities:

• 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.

Skills:

• 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.

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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

If you have site, country or departmental social media then feel free to switch any of the above links.

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.