- Represent the US for regulatory science
- Provide regional strategic regulatory expertise as regulatory representative to Global Regulatory Strategy Team (GRST).
- Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals
- Be accountable for timely submissions and approvals and aligning the regulatory strategy with global and business regional needs.
- Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s) within designated region
- Role can be combined with other Regulatory Role(s) (i.e. regional EM or US lead and/or Global Regulatory Lead for other programs), Project(s) assigned can be in development and/or at post-authorization stage
- This is an individual contributor role.
- Accountable for ensuring US regional contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects
- Provides regulatory expertise and leadership for the project/product.
- Ensures regulatory contributions achieve the strategic objectives, achieve agreed standards, maximizing overall project delivery time
- Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.
- Partners with customer groups (e.g. RU/BU, Regional commercial teams) to ensure required regulatory contributions (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 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
- Ensures business compliance and implementation of and adherence to regulatory standards
- Ensures rapid reporting of key project/product regulatory milestones and/or issues to the Franchise lead/GRPL and other stakeholders as required.
- Develop and maintains, directly or indirectly, constructive working relationships with Health Authority contacts in the assigned region
- Scientific Degree. BS is required. MS, PharmD or PhD preferred. Equivalent workplace experience can be considered.
- Proven experience as a national and/or regional regulatory strategist for at least one product in different therapeutic areas and in different stages of product development. Extensive direct regulatory experience
- Advanced knowledge of US FDA
- Vaccines Experienced preferred
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Pfizer: Director, US Regional Regulatory Strategist - Pearl River, United States - AAAS
Description
We have an exciting opportunity for a Director to join our vaccines Global Regulatory Science team as a US Regional Regulatory Strategist (RRS).
This is an excellent opportunity to join a growing and dynamic team and be in charge of various projects. We are looking for candidates with a dynamic and agile profile with a scientific background, and strong regulatory experience. The candidate should be passionate for vaccines, willing to learn and advance in their career.
As well as supporting the regulatory strategy from a regional perspective, you will partner with project teams and other customer groups to ensure regulatory requirements meet business needs.
ROLE SUMMARY
ROLE RESPONSIBILITIES
QUALIFICATIONS
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Occasional travel may be required
The annual base salary for this position ranges from $161,600.00 to $269, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments.
Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire.The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.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. This position requires permanent work authorization in the United States.Regulatory Affairs
