Director, Regulatory Affairs, Personal Health Care

Job description

Job Location MUMBAI GENERAL OFFICE Job Description P&G was founded over 180 years ago as a simple soap and candle company. Today, we're the world’s largest consumer goods company and home to iconic, trusted brands that make life a little bit easier in small but meaningful ways. We've spanned three centuries thanks to three simple ideas: leadership, innovation and citizenship. The insight, innovation and passion of hardworking teams have helped us grow into a global company that is governed responsibly and ethically, that is open and visible, and that supports good causes and protects the environment. This is a place where you can be proud to work and do something that matters. Dedication from Us: You'll be at the core of breakthrough innovations, be given exciting assignments, lead initiatives, and take ownership and responsibility, in creative workspaces where new insights thrive. All the while, you'll receive outstanding training to help you become a leader in your field. It is not just about what you'll do, but how you'll feel: encouraged, valued, purposeful, challenged, heard, and inspired. What we Offer: Continuous mentorship – you will collaborate with peers and receive both formal training as well as day-to-day mentoring from your manager dynamic and encouraging work environment– employees are at the center, we value every individual and support initiative, promoting agility and work/life balance. Overview of the job Do you know that Personal Healthcare (PHC) is a fast-growing business unit and a strategic part of our global business growth strategy? It is a dynamic and evolving area with ample opportunities to grow and develop your skills and competencies. Keen to leverage your regulatory affairs expertise bringing new healthcare innovations to the market on brands like Neurobion, Vicks, Livogen, Evion or Zzzquil, engage regulators & policy makers to shape robust governance frameworks and groom the next generation of regulatory talent? We are looking for a talented and passionate individual to lead our India sub-continent regulatory team. The team is focused on driving robust compliance across base portfolio and delivering innovative, high-quality regulatory strategies and submissions that drive our Personal Healthcare business today and into the future. If this sounds exciting to you, read on! What Success Looks Like • Able to deliver regulatory strategies that enable breakthrough innovation for the brands, partnering multi-functionally across disciplines to bring an innovation to life from idea to market entry • Able to drive base portfolio operations with a robust compliance mindset, with pragmatism, while delivering against business objectives • Building P&G Health’s equity and thought leadership in healthcare, across the industry, regulators & policy makers rooted in strong science and robust quality practices. • Nurturing a business & technically competent high performing organization • Bringing an innovative and business solution minded attitude to bust barriers and unlock opportunities • P&G offers competitive holistic compensation and a wide array of opportunities to build a multitude of skills – technical, communication, leadership and more, which enable growth personally and professionally Your team Located across Mumbai (P&G GO) and our manufacturing sites in 2 States. You will report to a Senior Director based in Singapore and will be part of a dynamic R&D & Commercial team. Key Responsibilities • Provide strategic input to the Innovation pipeline to meet business objectives – proactively looking out for opportunities, synergies, and risks. • Ensure robust strategy and smooth execution for initiatives including high quality registration dossier in line with the most current requirements in timely manner. • Drive compliant base portfolio operations and effectively manage routine notices, inspections and regulatory changes in collaboration with subject matter experts. • Build P&G Health’s equity and thought leadership in healthcare, across the industry, regulators & policy makers rooted in strong science and robust quality practices. • Manage and grow a team of motivated and competent regulatory professionals with strong career planning • Collaborate with local & regional R&D, Medical, Commercial and Supply Chain leadership on broad business & organization matters • Ensure adoption and adherence of the teams to all relevant regulatory systems and processes Qualifications • Graduate with degree (Bachelors/Masters/PhD) in Pharmacy or Life Sciences. • 12-15 years of relevant experience in Indian regulations, corresponding activities and registration covering a range of categories – drugs, nutraceutical, medical devices, ayurvedic medicines and interacting with related government agencies. Experience with export markets such as Nepal and Sri Lanka would be an added advantage. • Demonstrated abilities to engage with regulators on challenging matters and negotiate to favorable outcomes • Knowledge and experience in GMP, GDP regulations. • Familiarity with Regulatory documentation systems will be an advantage. • Strong track record of people development and organization building • Strong leadership, strategic thinking and agility as projects pivot in new directions based on the latest findings. • High level of learning agility, integration and influencing skills • Strong communication and collaboration skills - Ability to interact, engage and