Manager, Regulatory Affairs Strategist

What You Will Achieve

• Create and deliver strategic regulatory guidance for assigned projects/products in Emerging Markets. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines

• Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects.

• Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.

• Indirect liaison with regulatory authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.

• Lead and/or participates in Regulatory Teams for assigned projects/products.

• Develop and implements regulatory strategies to support/maintain registrations. Maintains product licenses across all product platforms.

• Understand regulatory environment and communicates priorities to global stakeholders

• Deliver project /product strategy incl. label, risk assessment, and PRS for assigned projects/products

How You Will Achieve It

• Accountable for ensuring or contributing to Global/Regional Regulatory Strategies for Emerging Markets 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, and minimize resource demands while 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, Brand Teams, Global supply, etc.) to ensure required regulatory contributions (e.g. briefing documents, line plans) 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 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 and CMC Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning's 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.

Qualifications

Must-Have

• Bachelor's Degree
• 5+ years of experience
• Experience in Over the Counter or pharmaceutical industry, with experience in the global regulatory environment
• Regional/Country regulatory experience including submission processes and product life cycle management activities
• Knowledge of commercial activities and Current Good Manufacturing Practices (part of GxP)
• Ability to work well cross functionally and to develop productive/collaborative relationships
• Strong written and verbal communication skills

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Experience of conducting, managing or participating in the audit process

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Project teams may be on US and/or EU timing, support for all regions in Emerging Markets.

Work Location Assignment:Flexible

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Regulatory Affairs