Work as Senior Manager in Regulatory Affairs at Pfizer

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Post : Sr Manager, Regulatory Affairs

Job Description
The PCO based Sr Manager GRA is responsible to lead, manage and provide strategic direction and oversight to the Country based regulatory teams to develop and execute regulatory strategies and plans for the country and region, where applicable. He would represent GRA on 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. This position will represent Pfizer in relevant industry associations and work closely with Director RA to implement country LT objectives.

Primary Responsibilities
• Delivery on compliance in assuring and fulfilling the regulatory performances in India.
• Lead and manage the local RA team members in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Ensure that local RA teams provide strategic regulatory input into WRS global regulatory strategies, thus providing optimal support for meeting local business objectives.
• Develop strong partnerships with in-country (e.g. BU Leads, Medical, Marketing, Supply Chain) and WRS-EM 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 WRS-EM needs to contribute to achieve business objectives.
• Responsible for the development, leadership and performance management of the local RA 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 lifecycle of a product. 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 all 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.
• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems (e.g. CMC change control, product labelling, etc.) are in place, and that the local RA staff are properly trained in these systems and procedures.
• Oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established WRS-EM 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.

Candidate Profile
• Scientific Degree. A higher degree (MS or PhD).
• Pharmacist degree is preferred with Masters .
• Appropriate regulatory experience in industry – minimum 10-12 years’ experience
• Management Degree (Undergraduate or MBA) may be an advantage.

Additional Information
Qualification : MS or PhD
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 25th January, 2020