Senior Associate, Global Regulatory Strategy for Oncology

Role Summary

Senior regulatory professional accountable for contributing to Global Regulatory Strategies and implementation plans (including core labels and risk registers) for assigned oncology projects. Develops and submits product registrations, progress reports, supplements, amendments, and periodic experience reports, and ensures regulatory plans are monitored with risks mitigated. Works with cross-functional teams to reach aligned regional positions and engages Health Authority contacts as appropriate.

Responsibilities

• Accountable for ensuring US/regional 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 expectations, maximizing overall project delivery time and probability of success and facilitating post-filing activities.
• Partners with key cross functional stakeholders in the Project Teams to ensure required regulatory contributions (line plans, label, NDA/sNDA, IND/CTA, MAA/IRD, variations, license renewals etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.
• Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports.
• Ensures regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks mitigated.
• Work with a certain degree of independence on moderately complex assignments and ensures an aligned regional regulatory position is reached 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 OGRS-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.

Qualifications

• Required: Bachelor's degree with at least 2 years of experience
• Required: Effective delivery in a complex matrix environment
• Required: Regulatory experience, including knowledge of New Drug Application (NDA) and Investigational New Drug (IND) submission processes
• Required: 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 (equivalent experience, either at a regulatory agency or working on substantive industry-government collaborations, can be considered)
• Preferred: Experience in communicating with FDA as well as participating in/leading such interactions
• Required: In-depth understanding of national and regional regulatory legislation and guidelines
• Preferred: Proven ability in developing and implementing regulatory strategy; experience preparing and submitting INDs and/or CTAs, NDAs, amendments/supplements
• Required: 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
• Preferred: Presentation skills - effective in formal presentation settings

Skills

• Communication skills
• Presentation skills

Education

• Bachelor's degree (Required)
• Master's degree is highly desirable (Preferred)