Job Description

Role:

The purpose of this position is to:

• 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 regional regulatory environment and communicates priorities to global stakeholders
• Support delivery of project regional strategy
• Sit on Regulatory Team and contribute aligned (ie with other regional players) regional strategy
• As appropriate accountable for regional regulatory agency interactions

JOB 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, risk registers) developed for assigned project/s
• Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, 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 relationship 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 change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy 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

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

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Pfizer