Regulatory Affairs Manager II

• Submission delivery strategy of all dossiers including established brands and all application types per market and /or region including Divestments, Marketing authorization transfer (MAT) and withdrawals.
• Provide scientific contribution to single documents such as PSRs, response documents, , regulatory maintenance documents Risk Management Plans, , Addendum to Clinical and NonClinical Overview, Pharmacovigilance agreement (PVA), Core labelling documentation (e.g. Company Core Data Sheets, USPI, EUQRD and Core Safety Profiles), etc.
• Analysis of regulatory procedures and special designations used during development, authorization and extension of the product.

Minimum Requirements –Education and Experience

• Relevant University Degree in Science or related discipline
• Minimum 8+ years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets General knowledge of drug development
• Thorough knowledge of the regulatory product maintenance process
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams.

Preferred Experience

• The US Regulatory affairs experience
• Managed regulatory deliverables at the project level
• Experience of working with people from locations outside of India, especially Europe and/or USA

Skills and Capabilities

·       Excellent English written and verbal communication skills

·       Cultural awareness

·       Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions

·       Proficiency with common project management (e.g., MS Project) and document management tools

·       Basic understanding of emerging technologies like AI, ML etc

·       Demonstrate ability to use digital tools and solutions relevant to own work tasks to support productivity, collaboration and learning

·       Work proactively to understand future needs and opportunities for digital transformation that improve the effectiveness and speed of core business processes and decision making.

·       Ability to work independently and as part of a team 

·       Influencing and stakeholder management skills

·       Ability to analyze problems and recommend actions

·       Continuous Improvement and knowledge sharing focused

Internal and External Contacts/Customers

• Global Regulatory Leads (GRLs)
• Regulatory Regional Leads (eg, US, EU, International RADs)
• Lead RPM
• Other R & D skill groups, eg, Clinical, Clinical Operations, GRO, Labeling, Reg CMC, Operations regulatory, Patient Safety, Regulatory Central, GRL, Regional Leads. Operations/Manufacturing organization (CMC post approval)
• Marketing Companies/Local affiliates
• Health Authorities
• External collaboration partners

Reporting Relationship

·       Direct Reports - None

·       Indirect Reports -None

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. To fully experience our collaborative, in‑person environment, candidates who are not currently based in the job location will need to relocate. In line with our company policy, relocation support is offered for moves within the country, ensuring a smooth transition.

Join us in our unique and ambitious world.

Why AstraZeneca:

Here, your regulatory expertise directly shapes how our medicines reach patients. We bring unexpected teams into the same room to unleash bold thinking, challenge assumptions, and craft innovative data packages that earn the best possible labels. You will operate at pace, influence strategy early, and collaborate across modalities while adopting new technologies and automation to drive efficiency. It is a supportive environment where we value kindness alongside ambition, encourage curiosity, and empower quick decisions—so you can stretch your skills, grow your career, and see your impact on approvals that matter.

Where Can I Find Out More?

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

Call to Action:

If you are ready to lead global maintenance submissions, elevate labels, and accelerate patient impact, step forward and join us to make a measurable difference now!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

Date Posted

08-Oct-2026

Closing Date

31-Oct-2026

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.