Regional Regulatory Strategist, Manager (RRS)

ROLE SUMMARY

· Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) level (if one in place)

· 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 for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s) within designated region.

· Project(s) assigned can be in development and/or at post-authorization stage.

ROLE RESPONSIBILITIES

· Accountable for ensuring 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 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, BLA, 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 GRL 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 WRS-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.

BASIC QUALIFICATIONS

· BS degree required.

· Minimum 5 years of regulatory experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas ( rare disease ex perience preferred) and in different stages of the product life cycle.

· Experience in communicating with FDA as well as participating in/leading such interactions.

· Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.

· 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 QUALIFICATIONS

• Master's degree with 3 years of regulatory experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas (rare disease experience preferred) and in different stages of the product life cycle.
• Relevant pharmaceutical experience

PHYSICAL/MENTAL REQUIREMENTS

None

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel may be required

Other Job Details

Eligible for Employee Referral Bonus

Last Day to Apply: August 27th 2021

Additional Location Information: US Remote

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