Manager, Oncology Regulatory Strategy

Use Your Power for Purpose At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail.

Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health. What You Will Achieve The primary purpose & key accountabilities of the role:
Represent Rest of World (ROW) region for regulatory sciences. Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST). Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals. Accountable for timely submissions and approvals with commercially attractive labeling in the designated region Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region.

The primary responsibilities critical to the role are:
Accountable for ensuring regional (ROW) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects. Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post-filing activities. Partners with project teams and other customer groups to ensure required regulatory contributions (line plans, label, CTA, MAA/IRD, variations, license renewals etc.)

meet business needs and are provided to the project teams, to agreed time and quality standards. Ensures regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) 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.

Engages in appropriate activities in order to influence the regional regulatory environment through Oncology GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate. Ensures business compliance and implementation of and adherence to Regulatory standards. Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region. Here Is What You Need (Minimum Requirements) Scientific Degree.

A higher degree may be an advantage but is not essential. Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country. Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable.

Equivalent experience, either at a regulatory agency or working on substantive industry
-government collaborations, can be considered. Knowledge of drug development practice rules, regulations and guidelines
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. Proven ability in developing and implementing regulatory strategy
- Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations. Communication skills
- Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management. Presentation skills
- Is effective in a variety of formal presentation settings; one- on-one, small and large groups, with peers, direct reports and senior manager. Negotiation skills
- Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. ORGANIZATIONAL RELATIONSHIPS Reports to ROW Regulatory Strategy Lead, Oncology Works with GRS colleagues and relevant project team(s) members (i.e. Clinical and Project Management, Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).

Partners with regional colleagues, including GRS-in Country colleagues, Medical and…