- Supports regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers, intelligence) for assigned project(s) across categories.
- Works across programs to support INDs / CTAs / renewals preparation and submission activities, regulatory systems updates and compliance, regulatory correspondence archiving, rapid response team activities
- 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. RU/BU, Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, CTA, MAA/IRD, variations, license renewals etc) meet business needs and are provided to the project teams, to agreed time and quality standards.
- Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated
- Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the regional business are championed and communicated
- Engages in appropriate activities in order to influence the regional regulatory environment through GRS-In Country colleagues, Agency contacts and/or Trade Associations as appropriate
- Ensures business compliance and implementation of and adherence to Regulatory standards
- Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region
- Bachelors degree required; 0-2 years of experience
- Knowledge of drug development practice rules, regulations and guidelines - familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines
- Career aspiration in developing and implementing regulatory strategy - Basic understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs desirable. Understanding of key concepts of product label aligned to target product profile and corporate expectations. Prior experience working with regulator(s)
- 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
- Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers
- Negotiation skills - Can negotiate skillfully and diplomatically in tough situations with both internal and external groups. Gains trust quickly of other parties to the negotiations
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- PharmD / PhD / MSc preferred
Travel up to 10% may be required
Work Location Assignment:Flexible
*Last date to apply is April 8, 2023*
The annual base salary for this position ranges from $62,800.00 to $104,500.00. In addition, this position offers an annual bonus with a target of 7.5% of the base salary. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.
Relocation assistance may be available based on business needs and/or eligibility.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.