Specialist Regulatory Affairs LCM - Strategic Growth Products

Job Title: Specialist Regulatory Affairs LCM- Growth Products Location: Andheri, Mumbai (Hybrid working) About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Specialist Regulatory Affairs – LCM Strategic Growth Products to join our Regulatory team. To perform life cycle maintenance activities for the Marketing Authorizations (MA) held by ADVANZ PHARMA for the Strategic Growth Products, with a focus on keeping MA up-to-date and ensuring supply continuity and compliance. Strategic Growth Products will include Innovative Medicines (NCEs or Biologics), Biosimilars, and Specialty Generics that will require significant technical input on the CMC and Clinical sides during the post-approval phase. While the post approval responsibilities of Biosimilars would sit with this role through the life cycle of the product, there will be a transition of responsibilities for Innovative Medicines and Specialty Generic products following completion of post approval commitments (Clinical or CMC/Manufacturing in nature) to the LCM Established Products team. What You'll Be Responsible For Support New Product Introduction (NPI) activities, including label/mock-up approvals, translations, and management of national phase procedures for DCPs. Serve as the primary Regulatory contact for Health Authorities and internal stakeholders following Marketing Authorisation approval. Partner closely with the NPI Product Lead to gain expertise in MA procedures, Health Authority interactions, key commitments, and post-approval requirements supporting launch and supply continuity. Lead post-approval regulatory activities in collaboration with cross-functional teams, including renewals, variations, maintenance activities, regulatory commitments, shortage notifications, PIP compliance, orphan designation maintenance, and labeling updates. Act as Global LCM Product Lead for assigned molecules (primarily biosimilars), driving regulatory submission plans, post-approval strategies, and cross-functional alignment across all registered markets. Collaborate closely with Regulatory SMEs across Biosimilars, Specialty Generics, Innovative Medicines, and Biologics to develop and execute product lifecycle strategies. Support Scientific Advice activities, including preparation of briefing packages, inspection readiness, and development of post-approval regulatory strategies. Support market expansion initiatives by leading or contributing to regulatory submissions for approved products entering new territories. Maintain regulatory handover documentation to ensure seamless transition of responsibilities to Established Products teams where applicable. Contribute to M&A regulatory activities, including due diligence and integration of acquired assets, particularly products with complex regulatory obligations. Drive continuous improvement initiatives, identifying opportunities and supporting implementation of process enhancements. Act as process owner for delegated regulatory procedures and governance activities. Support Health Authority inspection readiness and ensure timely completion of deviations, CAPAs, and assigned compliance actions. Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Have a bias for action and fast decision-making. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Drive the spirit of “One Team” by working collaboratively across all business functions with open, honest, and respectful cooperation. Contribute to making ADVANZ PHARMA a desired place to work. What We're Looking For We're looking for ambitious, resilient, and commercially minded professionals who are passionate about improving patient outcomes and driving business growth. For this role, you will also have the following: Qualifications: Graduate or Post Graduate in any discipline of Science, preferably life science / Pharmacy Formal training in Regulatory Affairs Knowledge, Skills & Experience: 8-10 years of experience handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Significant Biosimilars regulatory experience for EU – preferably Life cycle activities Good understanding of ICH and regional regulatory guidelines – should be able to interpret guidelines and apply them in practical situations independently Well-versed with EU/UK Regulatory procedures and processes Good understanding of CMC requirements of different dosage forms, i.e., solid orals, liquids, parenteral etc, and ability to technically review a complex CMC document and contribute towards development. Excellent communication skills, both oral and written, to connect with senior management internally & in third-party suppliers or service providers. A positive and ‘can-do’ approach , biased towards finding solutions and embracing change Inspired by our values of entrepreneurship, speed and integrity. Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ PHARMA grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. Why join ADVANZ PHARMA? At ADVANZ PHARMA, our purpose is clear: improving patients' lives by increasing access to medicines that matter. We are a fast-growing international pharmaceutical company where employees have the opportunity to make a tangible impact, take ownership, and contribute to meaningful work every day. A Place Where You Can Grow We foster a culture built on trust, collaboration, inclusion, and continuous development. Whether you're expanding your commercial expertise, taking on new challenges, or building your career within a growing organisation, you'll be supported to succeed. Entrepreneurial by Nature Our teams are empowered to make decisions, challenge convention, and create solutions that drive results. We value people who bring energy, accountability, and a desire to make things happen. A Meaningful Mission Every role at ADVANZ PHARMA contributes to improving access to important therapies for patients across the globe. The work you do will have a direct impact on healthcare professionals, healthcare systems, and ultimately the patients they serve. Flexibility and Support for Your Wellbeing Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work-life balance. Rewards & Benefits We are delighted to offer a comprehensive package designed to support the health, well-being, and professional growth of our employees. Global benefits: Global recognition programme Long Service Award Employee Assistance programme Birthday leave Wellbeing day Volunteering leave Compassionate leave Agile working [ for office-based employees only ] Work from Anywhere subject to local legislations [ for non field based employees only ] Our People Recommend Us We're proud that 82% of employees in our 2026 engagement survey said they would recommend ADVANZ PHARMA as a great place to work. If you're looking for an opportunity to combine commercial success with meaningful patient impact, Apply Now!