Senior Regulatory Affairs Manager

Company Description

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun pharma's global presence is supported by 50 manufacturing facilities spread across five continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2000 scientists and R&D investments of over 7% of annual revenues.

In addition to our strong position in generics, Sun Pharma is rapidly growing its Specialty / Innovative Medicines business, with a clear focus on developing and commercializing novel therapies across dermatology, oncology, ophthalmology, and other therapeutic areas. The company is making strategic investments to launch niche specialty targeting unmet medical needs.

About the role

As the primary regulatory lead for Sun Pharma's Specialty portfolio (innovative branded medicines) in Western Europe and ANZ, you will shape strategy, ensure compliance, and guide lifecycle planning to secure timely approvals. Through strategic oversight, you help deliver innovative therapies and strengthen Sun Pharma's market presence.

Responsibilities

• Coordinate MAA Marketing Authorisation Applications (MAAs) submissions closely with project management teams, local and global Subject Matter Experts (SMEs) and manage associated risks.
• Develop and implement regulatory strategies aligned with Target Product Profile (TPP) and business goals.
• Lead scientific advice and Paediatric Investigation Plan (PIP) procedures; prepare high-quality briefing documents.
• Ensure compliance with EU and national regulations and guidelines throughout product lifecycle.
• Represent RA in cross-functional leadership teams and external interactions with health authorities.
• Manage third party service providers (regulatory consultants, promotional review, translation services etc.).
• Continuously improve local regulatory processes and systems.
• Level of responsibility: High

Competencies

Leadership

• Influences across functions and geographies; drives organisational change; represents RA in leadership forums.
• Drives positive organisational change and collaborates cross-functionally between local, regional, global teams, demonstrating clear communication and results orientation.
• Builds influence across internal teams and with external stakeholders (health authorities, associations, etc.).

Technical Competencies

• Expert in EU regulatory frameworks, submission procedures, GMP/GCP/GVP guidelines; strong project management skills
• Expertise in Module 1 requirements and EU dossier structure.
• Ability to navigate complex cross-functional priorities (medical, commercial, market access).
• Experience in converting global dossiers for regional compliance.
• European Directives, Regulations and guidance documents related to obtaining and maintaining marketing authorisations of human medicinal products.
• European regulatory submissions (Centralised Procedure, Decentralised Procedure, Mutual Recognition Procedure) for innovator chemical / biological human medicines (MAAs, life cycle management).
• Clinical Trial Regulation.
• Pharmaceutical development and pharmaceutical manufacturing processes.
• Proficient in Microsoft Office, SharePoint, electronic document management, learning management systems, regulatory tools. Familiarity with AI tools.
• Fluent in English.

Behavioural Competencies

• Demonstrates accountability, initiative, and strong project management across multiple priorities.
• Collaborative mindset with clear, impactful communication.
• Adaptability and analytical thinking in dynamic environments.

Sun Pharma values

• Strives to develop and preserve long-term internal/external customer relationships.
• Takes actions to meet or exceed customer expectations.
• Understands the Pharma business, specifically the Specialty Pharma, and is aware of business trends.
• Is professional and credible. Understands the big picture.
• Holds domain knowledge; is a domain expert and stays updated.
• Delivers on commitments and is able to apply expertise to problems.
• Demonstrates professional maturity at all times and conveys functional perspective to others.
• Is decisive; takes responsibility.
• Ensures that stakeholders are well informed.
• Understands and uses key business indicators.
• Troubleshooting and prioritizing across Local/Global RA and Cross-Functional Teams.
• Works collaboratively with others and provides guidance to achieve group and business goals.

Quality of Service & Working Relationships

• Maintains a focus on excellence.
• Consistently delivers high quality services to customers (internal & external).
• Drives formalization and improvement of processes; develops and implements new procedures in collaboration with relevant stakeholders.
• Drives quantification and tracking.

Commercial & Cost Control

• Holds awareness of budgets.
• Delivers value at least costs. Highlights where additional investments would materially improve productivity or outcomes for the business.

Why Join Us?

• Opportunity to shape regulatory strategy for innovative medicines across Europe and ANZ.
• Work in a global, collaborative environment with strong leadership exposure.