Regional Regulatory Strategist (Senior Manager, GRA-Rare Disease)

Employer
Pfizer
Location
Collegeville, Pennsylvania
Posted
Jan 03, 2022
Ref
4833525
Required Education
Masters Degree/MBA
Position Type
Full time

ROLE SUMMARY

  • Regional (US, EU, and/or EM) Regulatory Strategist providing regulatory contributions aligned to meet business needs in agreement with key stakeholders.
  • Lead regional regulatory milestones, deliverables, and process, strategically accelerating assigned projects in the innovative end-to-end Rare Disease portfolio (inclusive of lifecycle support), with timely submissions and approvals and commercially attractive labelling.
  • Partner with the Global Regulatory Sub‑Team (GRST) to implement an aligned regulatory strategy for assigned project / products.
  • Act as direct liaison with Health authorities in the designated region to facilitate the prompt review and approval of applications.
  • Enable early and late clinical development activities by providing regulatory advice.
  • As appropriate develop and implement regulatory strategies to support initial registrations. Maintains product licenses across all assigned products.
  • Strong knowledge of the regulatory environment and communicates priorities to global stakeholders.

ROLE RESPONSIBILITIES

  • Responsible for providing strategic regulatory expertise and leadership on assigned projects in the Rare Disease portfolio at all stages of development, including product lifecycle.
  • Develop, maintain, and implement Regulatory Strategies (including core labels, risk registers) for assigned project(s) across the product lifecycle.
  • Ensures regulatory contributions achieve the objectives of the strategy, achieve agreed standards, and maximize probability of success.
  • Leads and partners with project teams and other customer groups (e.g. RU, BU, and Commercial teams) to ensure required regulatory contributions (CTA/IND, MAA/NDA/BLA, supplements/variations, license renewals etc) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.
  • Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
  • Ensures an aligned regulatory position related to milestones, deliverables, and process is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated.
  • Works closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
  • Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
  • Ensures business compliance and implementation of and adherence to Regulatory standards.
  • Develops and maintains constructive working relationship with Health Authority contacts as appropriate.

BASIC QUALIFICATIONS

  • Scientific Degree; an advanced degree (MSc or PhD) may be an advantage as strong scientific understanding to enable regulatory product development is expected.
  • Direct experience with innovative regulatory strategies (i.e., in the US, EU, and/or EM) enabling full development programs including leading submissions and achieving approvals under expedited pathways.
  • Direct experience in communicating with major regulatory agency(ies) (ie FDA, EMA, Japan), as well as participating in/leading such interactions for meetings to advance programs collaboratively.
  • Prior experience with gene therapy development is desirable or has demonstrated skills with novel therapies, biologics, or new modalities.
  • Demonstrable experience to influence and deliver succinct messages in a complex matrix environment.
  • Strong strategic thinking, team working, problem solving, communication and interpersonal skills.
  • Knowledge of national/regional and global regulatory legislation and guidelines.
  • Knowledge and understanding of quality systems, processes, audit and inspections.

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 the ever-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. 

  
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.
 

PHYSICAL/MENTAL REQUIREMENTS

None

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel maybe required


Other Job Details

Eligible for Employee Referral Bonus

Additional Posting Locations: Collegeville, PA or Global (any Pfizer site)

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.

Regulatory Affairs

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