Job Description

Rubicon Technical is a technical service provider to the consumer healthcare industry. We work with medicines, medical devices, food supplements, cosmetics, and functional foods, providing expertise in regulatory affairs, medical affairs, development and formulation, clinical nutrition, pharmacology, trade marking, quality management, project management and artwork and pack copy.

Rubicon Technical is a solution driven business. Our skilled team of consultants pride themselves on 'thinking outside the box' and are responsible for providing a range of bespoke technical services to the pharmaceutical, nutraceutical, medical device, and cosmetic industries.

Role / Responsibilities:

Managing Regulatory Affairs Projects for a diverse client portfolio in the healthcare sector from SME to multinationals.

Provide regulatory advice and services for food supplements along with three other category areas from the following: medicines, foods, cosmetics, general products, medical devices.

Act as the lead for clients on weekly calls and be their main point of contact for all enquiries.

Manage and support the Food Business Operator/Responsible Person services for the business including maintaining oversight of all clients & products, monitoring progression of onboarding with other internal stakeholders and effectively tracking regulatory changes that impact the products represented.

Research and develop new offerings for the business and rollout across the business

Compliance reviews and detailed assessment of pack copy, formulations and advertising (Webpages, Social Media, TV, Radio, Digital media). Provide management review of work completed by other members of the Regulatory Team before it is returned to the client.

Providing regulatory strategy for NPD and market expansions,

Author scientific reports for clients on claims/safety/efficacy/substantiation etc.

Preparation of dossiers and filing of notifications and registrations in UK & EU

Support clients with regulatory documentation for non-EU export markets.

Project manage large pieces of work for a client; include project management from initial stages to completion of the project, co-ordination of inputs from different parts of the business, feedback to the client

Deliver training sessions/presentations internally to colleagues and/or to clients

Generate new business, e.g. from new client calls, expansion of business from existing clients and generating leads from trade shows

Monitors changes in regulatory landscape and keep up to date knowledge of UK/EU laws and guidelines.

Coach and mentor existing members of the Regulatory Team on new areas to help them develop proficiency in a subject area, including provision of training, overseeing their progression plan, and reviewing their work

Direct line management of new graduates joining the Regulatory Team

Provide cover and support to the Regulatory Director as required

Improve internal regulatory processes to reduce risks.

Participate and represent the company at external meetings

Requirements:

Minimum bachelor's science degree. Ideally master's or post-graduation qualification.

Significant experience in Regulatory Affairs within the consumer healthcare industry, ideally in a similar role.

Evidence of continued professional development and training.

Excellent attention to detail and ability to multitask.

Confident and able to make decisions.

Experience managing and mentoring colleagues.

Ability to occasionally travel to our office in The Netherlands and to visit clients and trade shows worldwide.

Job Types: Full-time, Permanent

Pay: 40,000.00-45,000.00 per year

Work Location: In person