Our client, a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory Regional Strategist (Emerging Markets) on an initial 6 Month contract to be based at their offices in either Surrey or Kent - this will be after COVID-19 and when the offices reopen.
To represent a particular region for regulatory affairs (Emerging Markets) and support the Global Regulatory Lead in regulatory affairs projects/activities on the GRT, labelling, project teams etc. To 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. Ensure optimal regulatory interactions with Health Authorities in relation to the assigned project(s) within designated region.
- Accountable for ensuring regional (EM) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
- Ensure 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.
- Partner 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.
- Ensure 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
- Ensure 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.
- Engage in appropriate activities in order to influence the regional regulatory environment through WRS-In Country colleagues, Agency contacts and/or Trade Associations as appropriate.
- Develop and maintain, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.
Education & Skills:
- Degree in any life sciences minimum.
- 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. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs.
- At least 5 years global regulatory experience in the pharmaceutical sector.
- 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.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
your application has been submitted