Principal Manager – TAPS | Pfizer | Chennai

Job Description

Job Purpose:

• Support a particular region/s for regulatory affairs (US, EU, or EM)
• Provide support for the Regional Regulatory Strategy contribution to the Regulatory Team that aligns with regional business needs
• Manage regulatory aspects of projects/products across the lifecycle, including the preparation and submission of correspondence and applications to regulatory agencies
• Act as direct/ indirect liaison with regulatory authorities / PCOs to facilitate the prompt review and approval of applications
• Participates in Regulatory Teams for assigned projects/products
• Supporting clinical development activities
• As appropriate develop and implement regulatory strategies to support initial registrations. Maintains product licenses across all product platforms
• Understand the regional regulatory environment and communicates priorities to global stakeholders
• Support delivery of project regional strategy
• Sit on the Regulatory Team and contribute aligned (ie with other regional players) regional strategy
• As appropriate accountable for regional regulatory agency interactions

Main Responsibilities:

The major duties and responsibilities will include but are not limited to:

• Supporting contribution to Global Regulatory Strategies and implementation plans (including core labels, and risk registers) developed for assigned project/s
• Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands whilst maximizing overall project delivery time and probability of success and facilitating post-filing activities
• Partners with project teams and other customer groups (e.g. Country Regulatory Managers and Regional Brand Teams) to ensure required regulatory contributions (CTA/IND, MAA/NDA/BLA, supplements/variations, license renewals, etc) meet business needs and are provided to the project teams, to agreed time, cost and quality standards
• Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives, or external threats) mitigated
• Ensures an aligned regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated
• Works closely with other Regulatory Strategists within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learnings, and quality standards
• Implements systems, processes, and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines
• Ensures business compliance and implementation of and adherence to Regulatory standards
• Develops and maintains constructive working relationships with Health Authority contacts, directly or indirectly as appropriate
• Contribute to the development of internal policies, processes, and procedures supporting the progression and maintenance of the Pfizer-established pharma/biotherapeutic portfolio dependent upon grade and position

Qualifications & Skills

Preferred Experience :

• Minimum 15 Years in the Regulatory Affairs function in a reputed Pharmaceutical Organization
• Proven examples of delivery across the Drug Discovery, Development, and Commercialization lifecycle, with demonstrable contribution in Regulatory Affairs, with appropriate support
• Proven ability to manage complex regulatory issues, with appropriate support
• Proven ability to consistently deliver to time, cost, and quality standards
• Moderate level of regulatory experience including knowledge of CTA/INDs and MAA/NDA/BLA submission processes

Preferred Attributes:

• Excellent oral and written English communication skills. Good conceptual, analytical, problem-solving, reasoning, and organizational skills. Should be changed to agile and have the ability to work in highly matrixed environments. Attention to detail and accuracy are required.
• The candidate ideally should have experience with effective teamwork, collaboration, and communication, and demonstrated leadership ability.
• Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to work flexible hours