Sr| Manager| Regulatory Strategy

The PCO based colleague Sr. Manager, Regulatory Strategist India is responsible to lead, manage and provide strategic direction and oversight to the Country based regulatory strategist teams to develop and execute regulatory strategies and plans for India and region, where applicable. This position would represent regulatory in critical strategy discussion forums and local Country Medical Council (or equivalent) to ensure collaborative connectivity with these key stakeholders (e.g. Commercial, Medical, Marketing etc.) and a more focused regulatory approach to supporting country business objectives. Responsibilities: • Lead and manage the local RA team in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations etc. Ensure that local RA teams provide strategic regulatory input into GRS-I Asia global regulatory strategies, provide optimal support for meeting local business objectives. • Develop strong partnerships with in-country (e.g., business unit leads, Medical, Marketing, Supply Chain) and GRS-I Asia Therapeutic Area and Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization. • Provide strategic contribution to the country (PCO) leadership team – anticipate what GRS-I Asia needs to contribute to achieve business objectives. • Responsible for the development, leadership and performance management of the RA strategy team to achieve company objectives. Develop and enhance the capabilities and capacities of the RA teams through the identification and implementation of training and development needs. • Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the development and line extension phase of a asset. Develop a long-term and positive relationship characterized by integrity, quality, compliance and leadership. Act in the capacity as the main liaison and primary contact for local government regulators with regards to strategic regulatory affairs related activities. • Active participation in local trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies and decision making. Positively influence local legislative initiatives that could impact the business. • Oversee and manage the completion of CTA, NDA and line extension submissions and approvals as per established GRS-IRSP- Asia performance metrics. • Responsible for ensuring that all regulatory activities (new product submissions, clinical trial applications, existing licenses, etc.) are compliant with local regulations, requirements and practices. • Implement technology solutions for enabling better information availability. • Demonstrate and promote Pfizer global value system across all interactions. • Contribute to Pfizer’s quality-consciousness and research-based image. • Delivery per country benchmarks. Experience & Skills: 10-15 years of Regulatory experience in Pharma industry. Bachelor's degree in a science subject required (MD, PhD advantageous) together with appropriate pharmaceutical industry experience gained within a global regulatory affairs function. Understanding of vaccines and immunology advantageous. Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation and awareness of the functioning of the pharmaceutical industry People Management Experience Ability to manage complex issues with appropriate support, such as global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management or leveraging regulatory policy issues to support commercial objectives. Strong problem-solving skills Self-aware and accountable Strong written and verbal communication skills. Fluent in English - written and spoken Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution. General management experience and previous line management and leadership experience middle management level is essential. Demonstrable experience of effective delivery in a complex matrix environment. Strong strategic, negotiating, communication, interpersonal and presentation skills Decision-making/ Business Orientation Judgment/ Strategic Thinking/ Negotiation/ Leadership Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Regulatory Affairs #LI-PFE Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place