Manager, Regional Regulatory Strategist - Global Brands

JOB SUMMARY

The purpose of this role is to:

• Represent a particular region for regulatory affairs (US, EU or EM).

• Provide regional strategic expertise to relevant forums (i.e., to the GMT, Global Regulatory Strategic Team (GRST), etc.).

• Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.

• Be accountable for timely submissions and approvals with commercially attractive labelling in the designated region.

• Be accountable as the main point of contact with Health Authorities in relation to the assigned project(s) within designated region.

• Role can be combined with other Regulatory Role(s) (i.e., Global Regulatory Lead).

• Provide operational support of activities as assigned (i.e., researching regulatory background for products in scope).

JOB RESPONSIBILITIES

• Accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels and risk registers) for assigned projects.

• Ensures regulatory contributions achieve the objectives in the strategy, to agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.

• Partners with project teams and other customer groups (e.g., RU/BU, Regional Commercial Teams) 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 is communicated to GRL and Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) are 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 to influence the regional regulatory environment through 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 relationships with Health Authority contacts in the assigned region.

• Maintenance of information in regulatory systems and support of regulatory systems incl. data analysis and mining.

• Support of operational activities as assigned including coordination of submissions, responses to regulatory queries, labeling activities, market requirements management, and other regulatory tasks.

• Support creation and maintenance of documents like internal trackers and submission documents incl. QC and gap analysis.

• Provide regular updates on work progress, highlighting any critical developments or emerging risks that may impact outcomes or require leadership attention.

QUALIFICATIONS / SKILLS

Education/Experience:

BS/BA (Pharmacy, Chemistry, Biology, or related science) with 5+ years of related technical experience or MS with 3+ years related technical experience or PhD with <2 years in the pharmaceutical industry with relevant technical experience.

Preferred Qualifications:

• Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process and/or post-approval study requirements.

• Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas, familiarity with generic/non-innovative registrations 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.

• Experience in communicating with FDA or major EU regulatory agency(ies) for US and EU regulatory strategists respectively, as well as participating in/leading such interactions, is preferred.

• 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, ND