Director, Regulatory Policy

Recruiter
Pfizer
Location
Sandwich
Salary
Negotiable
Posted
29 Apr 2022
Closes
29 May 2022
Ref
4852759
Hours
Full Time
Contract Type
Permanent

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 within our Global Regulatory Policy & Intelligence team as part of Global Regulatory Affairs. You will play the critical role of amplifying and extending Pfizer's position as a global thought leader for policy and advocacy to advance regulatory science topics and Pfizer's portfolio for the benefit of patients.

Your expertise and knowledge will help to proactively identify global and regional trends and changes in regulatory authority standards and the regulatory environment and influence their direction and outcome. In addition, you will design and implement strategic regulatory policy initiatives and provide recommendations for regulatory and Pfizer leadership on how the business should address global and regional regulatory challenges.

Your leadership skills and innovative ideas will lead the development and implementation of strategic and tactical plans to advance Pfizer's priority regulatory policy topics.

Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.

How You Will Achieve It

  • Identify, analyse, interpret, and communicate the impact of regulatory environmental trends and regional policy issues
  • Leading and participating in cross-functional teams to develop Pfizer policy and positions on key regulatory issues
  • Leading development and execution of global regulatory policy and advocacy for one or more high-priority regulatory science topics
  • External advocacy on key regulatory policy issues by:
    • Leading interactions with trade association and other industry organizations through direct participation or working alongside Pfizer's representatives
    • Direct or indirect interaction with regulators on priority regulatory policy topics
    • Support regulatory advocacy by senior leadership in GRA and Pfizer
  • Advising GRA leadership and strategists on regulatory topics and provision of technical and regulatory subject matter expertise to scientific advisory councils and other teams
  • Generation of in-depth briefings on regulatory policy topics
  • Use and onward provision of gathered regulatory intelligence both reported and through direct interaction with regulators, policy makers, and industry associations
  • Develop and maintain systems, processes and procedures relating to regulatory policy productivity improvements
  • Contribute to overall success of GRPI by partnering with full GRPI team to amplify our impact to patients, Regulatory and Pfizer



Qualifications

Must-Have

  • Degree or equivalent experience in human or natural sciences
  • Knowledge of regional regulatory environments and impacts on regulatory strategy and implementation.
  • Knowledge of drug development practice, rules, regulations, and guidelines.
  • Familiarity with factors likely to influence the regulatory environment.
  • Communicates accurately and impactfully. effectively using a variety of mediums appropriate to the setting, (written and verbal)
  • Can negotiate skilfully and build consensus in tough situations with both internal and external groups

Nice-to-Have

  • Prior Experience in drug development, regulatory affairs and/or policy
  • Knowledge of the political and governmental process that impact the regulated pharmaceutical business
  • Appreciates regulatory agency philosophies, guidelines, and process and how they impact on regulatory strategies.
  • Can identify issues and challenges and work with partner groups to develop options that will help implement agreed solutions



The closing deadline for applications is May 15th.

All applicants must have the relevant authorisation to live and work in the UK / home country as applicable.


Similar jobs

Similar jobs