Regulatory Affairs Consultant
3 days ago
Tadworth
• 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 timely submissions and approvals with commercially attractive labeling in the designated region., • 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). JOB RESPONSIBILITIES • 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. JOB DESCRIPTION • 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., • Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region. QUALIFICATIONS / SKILLS • Scientific Degree. A higher degree may be an advantage but is not essential., • 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. 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., • 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