Quality Consultant

2 weeks ago

Tadworth Surrey, United Kingdom Cpl Life Sciences Full time

Regulatory Affairs Consultant – EU Strategy
~ UK-based, Hybrid – 3x a week on-site in Surrey, UK.
~10-to-12-month contract – Inside IR35
~ PAYE rate up to £33.78 p/h OR Umbrella rate up to £37.86 p/h JOB SUMMARY
~ Represent a particular region for regulatory sciences (US, EU or EM)
~ 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 ensuring optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region.
~ Role can be combined with other Regulatory Role(s) (i.e., Global Regulatory Lead).


Accountable for ensuring regional (US, EU or EM) 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 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 communicated to Global Regulatory Lead 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.


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.
Scientific Degree. 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.
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 f actors 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. 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.

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