Manager, Regional Regulatory Strategist

ROLE SUMMARY

• Represent United States (US) Regulatory Affairs
• Provide strategic expertise as a member of the Global Regulatory Strategic Team (GRST)
• Lead and implement US regulatory strategies in agreement with key stakeholders for assigned projects and in line with the commercial goals
• Be accountable for timely submissions and approvals with commercially attractive labelling
• Be accountable for ensuring optimal regulatory interactions with US FDA in relation to the assigned projects
• Projects assigned can be in development and/or at post-authorization stage

ROLE RESPONSIBILITIES

• Accountable for ensuring US contribution to global regulatory strategies and implementation plans for assigned projects
• Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities
• Partners with project teams and other customer groups (e.g. Clinical Study Teams; Post-Authorization Study Teams; Program Management; Worldwide Safety) to ensure required regulatory contributions meet business needs and are provided to agreed time and quality standards
• Ensures regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management and any risks (from emerging data, changing internal objectives or external threats) mitigated
• Ensures an aligned US regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions are championed and communicated
• Ensures business compliance and implementation of and adherence to Regulatory standards
• Maintains internal regulatory databases, tracking and document management systems as appropriate
• Supports query and commitment management in collaboration relevant stakeholders
• Develops and maintains, directly or indirectly, constructive working relationship with FDA contacts
• Engages in appropriate activities in order to influence the US regulatory environment through Regulatory colleagues, Agency contacts and/or Trade Associations as appropriate

BASIC QUALIFICATIONS

• BS degree required. A higher degree may be an advantage but is not essential.
• Minimum 5 years of US Regulatory Affairs experience
• Experience in regulatory management of a US IND, responses to FDA requests for information/FDA comments, and representing Regulatory Affairs in cross-functional teams
• Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines
• Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management

PHYSICAL/MENTAL REQUIREMENTS

Not applicable

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Limited travel may be required in the future

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

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