ROLE SUMMARY

The incumbent serves as a senior regulatory leader who has a global mindset, expertise of drug development and product lifecycle processes, and priorities including: a track record of successful regulatory achievements in developing and gaining approvals for obesity products, a leading voice that has influenced regulatory issues associated with obesity development,  and evidence of prior role as senior level point person for addressing commercial needs globally for all products and projects in an advanced obesity pipeline. The ultimate goal of this senior level position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products so as to optimize input to development and commercial decision-making and ultimately lead to approvals with optimal labels for Pfizer’s portfolio of obesity assets in PRD, and as the portfolio advances to support marketed products at times of product defense activities and oversee more routine regulatory maintenance activities for products later in their life cycle.   

Key Accountabilities:

Oversee the designated Portfolio at the governance, strategic and technical level  Be accountable for the Regulatory Strategies and effective Global Regulatory Sub Teams (GRST) working within the assigned portfolio, ensuring aligned regulatory positions in place and agreed that take account of regional needs Provide strategic guidance to projects and products through regulatory strategists reporting to him/her.  Model strong leadership and project management techniques to provide leadership to the GRS teams, committees or work units to develop objectives, strategy, and tactical plans for the portfolio, assuring a global focus of goals, strategies and plansResponsible for developing collaborative working relationships with the regulatory authorities and influencing emerging regulatory/policies in general and particularly in the assigned portfolio/disease areas Supervise US/EU regional regulatory strategist leads and/or Global Regulatory Leads (GRLs), and responsible for staff and talent development, career development and planning and performance management  Ensure regulatory deliverables in place and delivered to time, cost and quality for all projects in the portfolio (line plan/GRS/PRS/regulatory risks/labeling claims)Contribute to the IDMB Regulatory Leadership Team and drive the required culture and behaviors though the organization  Champion flexible approaches to ensure efficient and effective resource utilizationEnsure learning embedded in the organization

ROLE RESPONSIBILITIES

The incumbent serves as the senior global regulatory representative within the obesity disease area, at the governance, strategic, technical, and portfolio level responsible for regulatory decisions.

Provides regulatory expertise and leadership within the assigned portfolio, and other disease areas associated with obesity, as relevantIs responsible for developing and maintain an in-depth regulatory knowledge of the portfolio including current and emerging global guidelines and regulator’s latest thinking, relevant regulatory approaches and actions, and status of competitor products  Responsible for ensuring global regulatory strategies for all projects and products within the assigned portfolio, along with co-morbid disease areas associated with obesity, as relevant are developed and implemented  Partners with leaders in PRD, International and Commercial teams to develop strong global regulatory strategies for projects and products  Develops strong and positive working relationships with regulators, professional bodies, external experts and opinion leadersBrings in a depth of expertise to develop novel concepts and approaches to advance and/or challenge existing regulatory paradigms  Works closely with regulatory colleagues across sites, countries and BUs to ensure consistent approaches to Health AuthoritiesEngages in appropriate activities to influence the regulatory environment  Responsible for aggregate resource forecasting for the projects/products within assigned portfolioMentors, develops and coaches Regulatory Strategists/GRLs for projects within the relevant portfolio including all aspects of the performance management process as appropriateProvides guidance to all regulatory professionals with the area of responsibility to prepare for health authority interactions and external and internal project/product presentations Works with other regulatory senior leaders to ensure application of consistent processes and policies across GRS. Directly responsible for assuring implementation of these processes and policiesSupports the IDMB leadership team and drives the required culture and behaviors through the organizationChampions flexible approaches to ensure efficient and effective resource utilizationEnsures learning embedded in the organization

 

TECHNICAL REQUIREMENTS 

Global regulatory strategy experience in the cardiovascular, renal and metabolic disease (CVRM) areas. Has significant experience and track record of achievements in the obesity disease area and GLP-1 landscape, through prior regulatory experience, and direct product development  Proven ability in developing practice rules, regulators and guidelines - Understanding of regulatory agency philosophy and guidelines. Thorough expertise and track record in approvals of INDs/CTAs and NDAs /MAA/IRDs. Working with and influencing regulators and opinion leaders facilitating approval of submissions with labeling meeting corporate expectations  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 - Communicates effectively using a variety of medium appropriate to the setting. Is comfortable interacting at senior levels of the organization 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. Commands attention and can manage group process during the presentationNegotiation 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 

QUALIFICATIONS

Advanced Scientific Degree (M.D., Ph.D., Pharm.D., M.Sc.) or equivalent experience in drug, device, development and/or commercialization20+ years demonstrable experience in drug and/or device development or relevant experience in the Pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs / Health Authority and/or a proven track record of success in negotiating with Health Authorities and in representing interests to internal and external stakeholdersKnowledge and successful direct regulatory experience with assigned obesity therapeutic areas / as well as CV, renal and metabolic disease areasIn depth and relevant global regulatory experience in this therapeutic area (multiple regions / major markets)  Demonstrated strategic thinking and ability to integrate strategies into actionable plans  Proven ability to function autonomously at a senior level in a highly matrixed organizationDemonstrable experience of managing and developing others and leadership 

Last Date to Apply for Job: November 15, 2024

The annual base salary for this position ranges from $239,300.00 to $398,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% 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