Senior Manager, Regulatory Policy

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.

ROLE SUMMARY
- You will represent Pfizer within our International Regulatory Science Policy Team as part of Global Regulatory sciences. You will play the critical role of helping to amplify and extend Pfizer’s external positions as a regional regulatory policy expert specializing in Asia. However, you will also work cross regionally on AFME, LATAM and/or Multi
- Lateral Organization, (MLO) Advocacy as required. You will be a 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 regional and cross 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 help to provide recommendations for regulatory and Pfizer leadership on how the business should address cross regional and regional regulatory challenges.
- Your leadership skills and innovative ideas will help to lead the development and implementation of strategic and tactical plans to advance Pfizer’s priority International 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.
- ROLE RESPONSIBILITIES- Helps to identify, analyse, interpret, and communicate the impact of regulatory environmental trends and regional and cross regional policy issues-
- Working with leaders, and participating in, cross-functional teams to develop Pfizer policy and positions on key regulatory issues-
- Leading development and execution of cross regional and regional regulatory policy and advocacy for one or more high-priority regulatory science topics-
- External advocacy on key regulatory policy issues by:- Managing Pfizer’s 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 GRS and PfizerGeneration 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 International Regulatory policy and wider IRSP by partnering with team to amplify our impact to patients, Regulatory and PfizerBASIC QUALIFICATIONS- Degree or equivalent experience in human or natural sciences-
- Knowledge of Asia regional regulatory environment and able to see cross regional impacts as well as impact on regulatory strategy and implementation.-
- Pharmaceutical Industry knowledge of drug development practice, rules, regulations, and guidelines.-
- Awareness of factors likely to influence the regulatory environment.-
- Communicates accurately, impactfully and effectively using a variety of mediums appropriate to the setting, (written and verbal)-
- Effective stakeholder management and organizational awareness-
- Can negotiate skillfully and build consensus with both internal and external groupsPREFERRED QUALIFICATIONS- Prior Experience in drug development, regulatory affairs and/or policy-
- Knowledge of the political and governmental processes that impact the regulated pharmaceutical business-
- Awareness of 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 solutionsPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

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