Global Regulatory Lead/ Regional Regulatory Strategist (Director)

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
Feb 18, 2021
Closes
Feb 26, 2021
Ref
536027
Jobseeker Type
Professional
Organization Type
Corporate
Hours
Full Time
Role Description

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage,joy, equity and excellence. Ourbreakthrough culture lends itself to our dedication to transforming millions of lives.We value every employee and throughout their careerencourage them to grow, developand express their viewsfreely.

  • Global Regulatory Lead (GRL) and Regional (US or EU) Regulatory Strategist providing regulatory contributions aligned to meet business needs in agreement with key stakeholders.
  • Be accountable for regulatory milestones, deliverables, and process for a high priority approved product, and other early projects in Rare Cardiology, including timely submissions and approvals with commercially attractive labelling.
  • As GRL, lead the Global Regulatory Sub-Team (GRST) to provide an aligned regulatory strategy for assigned project / products across the lifecycle.
  • 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.


Responsibilities
  • Responsible for providing strategic regulatory expertise and leadership on a high priority approved product, and other projects in Rare Cardiology as assigned.
  • Develop, maintain, and implement Global 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, minimize resource demands whilst maximizing overall project delivery time and probability of success, and facilitating post filing activities.
  • 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.
  • Mentors regulatory professionals as appropriate to meet the project/product objectives.


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.

BASIC QUALIFICATIONS
  • BS degree required. Equivalent workplace experience can be considered.
  • Minimum of 8 years of direct regulatory experience as regional and/or global regulatory lead, preferably in rare cardiology or cardiovascular therapeutic areas and across different stages of the product lifecycle.
  • Knowledge of regulations and guidelines and their associated challenges/opportunities for global development programs.
  • Direct experience with full development programs including leading submissions and achieving approvals.
  • Direct experience in communicating with major regulatory agency(ies) (i.e. FDA, EMA, Japan), as well as participating in/leading such interactions for milestone meetings.
  • Knowledge of clinical trial design and management, including data flow process and quality requirements for submission.
  • Experience working in a highly matrixed, global and multi-site environment.
  • Strong strategic thinking, project management, and problem-solving skills.
  • Ability to communicate complex information and analyses to teams and senior management - track record of having supported at least one project of high complexity.


PREFERRED QUALIFICATIONS
  • A higher degree (MS, PharmD, or PhD) is preferred.
  • Prior experience with gene therapy development is preferred.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Occasional travel may be required.


Other Job Details:
  • Last Date to Apply for Job: February 26, 2021
  • Eligible for Employee Referral Bonus: YES


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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.

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