* 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
o Represent a particular region for regulatory sciences (US, EU or EM)
o Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).
o Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
o Accountable for timely submissions and approvals with commercially attractive labeling in the designated region.
o Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region.
o Role can be combined with other Regulatory Role(s) (i.e., Global Regulatory Lead).
JOB RESPONSIBILITIES
o Accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
o 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.
o 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.
o 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.
o Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned.
JOB DESCRIPTION
o 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.
o Ensures business compliance and implementation of and adherence to Regulatory standards.
o Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.
QUALIFICATIONS / SKILLS
o Scientific Degree. A higher degree may be an advantage but is not essential.
o 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.
o 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.
o Equivalent experience, either at a regulatory agency or working on substantive industry -government collaborations, can be considered.
o 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.
o Knowledge of drug development practice rules, regulations and guidelines - Familiarity with f actors likely to influence the regulatory environment, including new and emerging guidelines.
o Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations.
o 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.
For more information, please reach out to me at lucy.kirkaldy@cpl.com