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US Regional Regulatory Strategist

Employer
Pfizer
Location
La Jolla, California
Salary
Competitive
Closing date
Sep 25, 2021

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Organization Type
All Industry, Pharma
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 .

What You Will Achieve

You will represent Pfizer as an Approval Liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the Regulatory Liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments, and periodic experience reports.

As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges , and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.

It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe .

How You Will Achieve It
  • Provide regional (US-specific) expertise
  • Accountable for ensuring US contribution to the Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
  • Ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success.
  • Partner with project teams and other customer groups to ensure required regulatory contributions meet business needs, to agreed time and quality standards.
  • Ensure regulatory plans are monitored, progress/variance communicated to the Global Regulatory Lead and Senior Management and any risks are mitigated.
  • 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.
  • Develops and maintains constructive working relationship with Health Authority contacts in the assigned region.
  • Understand US regulations and developing trends in the regulatory environment, provide assessment of the impact to key stakeholders .
  • Maintain compliance with regulations by ensuring that corporate regulatory processes, Standard Operating Procedures ( SOP ) and systems are in place, also ensure team is properly trained in these systems and procedures.
  • Maintain and update the Local Product Document (labeling) in accordance with relevant regulations and SOPs.
  • Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to assigned project(s).


Qualifications

Must-Have
  • Previous experience as a regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life-cycle . Equivalent experience, such as at a regulatory agency, can be considered.
  • Knowledge of the US regulatory environment and drug development . Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
  • Proven ability in developing and implementing regulatory strategy.
  • Bachelor's Degree(BA/BS) and 9+ years of experience .
  • Communication skills-ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format.
  • Presentation skills-effective in a variety of formal presentation settings.
  • Negotiation skills-can negotiate skillfully in tough situations with both internal and external groups. Can be direct as well as diplomatic.
  • Understan ding of b usiness and f inancial e nvironment .
  • Ability to manage multiple projects, create and manage project timelines.


Nice-to-Have
  • Master's degree (MA/MBA/MS) and 7+ years of experience.
  • Doctorate (PhD/PharmD/JD) with 4+ years of experience.
  • Thinks strategically with good project management skills .

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.

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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