Jobid=628838511795045377 (0.0322)
Who We Are
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$6 billion. Supported by more than 40 manufacturing facilities and more than 40.000 employees around the globe, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
Over the last two decades, Sun Pharma has established itself as a leading player in the generics market, and are rapidly ramping up their presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.
Values
At Sun Pharma our core values—Humility, Integrity, Passion, and Innovation—are part of our unique culture, known as Sunology.
We are empowering our employees to create their “Own Sunshine”. We believe in being Better Everyday by investing on lifelong learning, Taking Charge by owning our impact, and Thriving Together in a workplace where collaboration is encouraged. We are committed to being an inclusive and equitable employer, valuing diverse perspectives and creating an environment where all individuals feel respected, heard, and inspired to bring their best selves to work.
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.
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
Sun Pharma's core values are Quality, Innovation, Reliability, Consistency, and Trust. These values guide the company's mission to make healthcare more accessible by developing high-quality, affordable medicines and focusing on patient needs. Other guiding principles include Humility, Integrity, Passion, and Transparency.
• Quality: A commitment to getting things right the first time by building quality into every product and process.
• Innovation: Leveraging new technologies and ideas to address unmet medical needs and think ahead of the curve.
• Reliability: Maintaining efficiency and discipline in all processes and systems to ensure consistent delivery.
• Consistency: Consistently delivering value to stakeholders and ensuring products reliably deliver results.
• Trust: Being transparent in dealings and operating with integrity.
• Passion: A drive to improve health outcomes for millions of people.
• Humility: Recognizing the importance of all stakeholders and acting with humility.
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.
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