Due to security issues and the nature of the industry many of our clients require us to maintain their anonymity until a CV has been submitted. If you need more details about our current opportunities please submit your CV here. We will not put you forward to the client until we’ve discussed the role with you in more detail and you have agreed that it is a position you would like to apply for. We are only permitted to disclose certain information when we believe the candidate is qualified and is likely to reach the interview stage.
All Categories . Aerospace & Automotive . Biopharmaceuticals & Biotechnology . Chemicals . Electronics & I.T. . Energy, Environment & Utilities . Engineering . FMCG & Pharmaceuticals . Marine & Defence . Scientific
Senior Regulatory Manager
South East Ref: ABJ4900
As a Senior Regulatory Manager for a global organisation you will define the science and regulatory packages required to substantiate efficacy related claims and ensure these new active products fulfil the organisations regulatory obligations. As senior regulatory affairs manager you will part of group that now leads the scientific efficacy assessment of active ingredients to build internal scientific knowledge, support regulatory engagement and substantiate consumer claims across new product categories.
This is achieved through a weight of evidence approach to support internal company positions, external claims and scientific publications. The approach includes:
- Delivery of the efficacy science from pre-clinical; ‘in-use’ human behavioural, and clinical studies to measure individual effects substantiate claims and support regulatory submissions for product launches.
- Integration of technologies and capabilities to accelerate scientific understanding.
- Establishment of partnerships and collaborations to develop new capabilities to enhance science delivery.
- Supporting science communications and publications to drive engagement.
- Create a global regulatory science strategy for determining the efficacy of new actives portfolio, substantiating consumers claims and building science packages for regulatory engagement
- Contribute to the design, execution and reporting of studies required for the company to meet its business ambitions in the product efficacy space
- Advise on the scientific communication strategy to accelerate and sustain the company’s’ ambition in the New Actives space
- Lead and direct the work for the efficacy substantiation team in the areas of study design and execution to substantiate consumer facing claims and facilitate engagement with regulatory authorities
- Lead in monitoring the regulatory landscape to help shape and define the scientific studies and data required to fulfil our regulatory obligations
- Lead in assembling regulatory dossiers and contribute to external communications and publications.
- Work in partnership across the R&D community and teams to transfer and validate new methodologies into our portfolio for assessing product efficacy
- Work in partnership with legal and R&D compliance teams to define, build and execute science packages that will facilitate regulatory engagement with our suite of new products containing functional ingredients.
- Benchmark other industries to ensure our regulatory science landscaping and efficacy assessment framework is efficient and gives the best opportunity for leading in new product spaces
Qualifications, Education and Experience:-
- A good first degree in a relevant technical discipline
- Regulatory expertise developed through commercial experience and positive track record.
e.g. (Food / Pharma / Beverages / Biotech / FMCG/ Nutrition)
- Demonstrable working knowledge of regulatory formats, technical files and design dossiers
- Excellent written and verbal reasoning skills, coupled with the ability to communicate complex science to non-technical audiences
- Possess computer competency in Microsoft office software (Excel), data collection and general analysis tools;
- Maintains awareness of the current & emerging regulatory environment of functional foods, dietary supplements, vitamins, (desirable)
- Ability to manage upwards effectively and assertively, as well as within the peer group, to acquire the necessary information, and help drive and inform the decision-making process by the appropriately placed people (both at the senior and junior level).
They can offer an attractive salary up to 118k, commensurate with qualifications and experience as well as a Strong Bonus Scheme (90%), Car Allowance (c6k), Share Options, Contributory Company Pension Scheme and Subsidised Private Medical Insurance as part of a strong flexible benefits package.
To Apply Please contact Alison Basson at, quoting reference - Ref: ABJ4900 on 0203 909 3782, 07814547440 or reply via email, entering the job title and reference code in the subject field to email@example.com