Manager, Oncology Regulatory Strategy

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.

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.

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.