Director, Scientific Regulatory Strategy

San Diego, CA, United States

Work Location Assignment:Onsite/Hybrid

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and theever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will represent Pfizer as anApprovalLiaison in the regulatory affairs team. You will play the critical role of providing strategic regulatory expertise as Global regulatory representative to Product Team(s).

As a Director, Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from North America, Europe, Emerging Markets, Japan. Through the GRST, develop, align, manage and implement the global regulatory strategy.

Be accountable for:

Delivering the project goals and aligning the regulatory strategy with global and business regional needs.

Timely submissions and approvals with commercially attractive labelling across the regions.

Ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).

Role may be combined with other Regulatory Role (i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).

Project(s) assigned could be in development and/or at post-authorization stage.

How You Will Achieve It

Responsible for the production, updating and communication of global regulatory strategies for assigned projects/ products, mechanisms of action and/or indications.

Provides regulatory expertise and leadership for the project/product.

Member of appropriate Project(s)/Product(s) teams.

In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy.

Ensures appropriate representation for Pfizer for the project/product with Health Authorities.

Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.

Ensures that all regulatory development process commitments are clearly communicated, monitored and met.

Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy

Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives.

Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders.

Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRPL and other stakeholders as required.

Participates in appropriate governance committees, as necessary.

Qualifications

Must-Have

Bachelor's Degree(BA/BS)and 10+ years of experience. MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.

Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST.

Advanced knowledge of US FDA and/or EU regulations.

Working knowledge of other regulations and their associated challenges for global development programs.

Direct experience with at least US and/or EU submissions and approvals.

Direct experience in communicating with major regulatory agency(ies) (ie FDA, EMA, Japan), as well as participating in/leading such interactions such as End-of-Phase 2, pre-submission meeting(s).

Understanding of clinical trial design and management, including data flow process.

Experience working in a highly matrixed, global and multi-site environment.

Track record of having supported at least one project of high complexity and provided strategic direction.

Experience within different therapeutic areas and at different stages of products life cycle.

Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.

Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations

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 in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.

The annual base salary for this position ranges from $161,600.00 to $269,400.00. 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 | (uscandidates.mypfizerbenefits.com). 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

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