Regulatory Affairs Manager - Cosmetics (Non-Medicines)

Regulatory Affairs Manager - Cosmetics (Non-Medicines)

Teva

Harlow, United Kingdom

We are currently looking for a Regulatory Affairs Manager to cover a 12 month maternity leave. This is a full-time position joining the Non-Medicines RA team to support all registration activities for Non-Medicines OTC products (i.e., food supplements, cosmetics).

A day in the life of a Regulatory Affairs Manager - Cosmetics (non-medicine)...

New product initiatives:

  • Give central regulatory support to project teams and stakeholders;
  • Lead the regulatory assessment of the new products to be notified/registered (formulation, labelling, artwork);
  • Liaise with regions and countries to ensure products meets local requirements;
  • Provide initial and final regulatory strategies;
  • Ensure that technical dossiers are compiled and dispatched in accordance with work plan commitments and internal KPIs;
  • Close interaction with other functions across R&D to gain early visibility of product formulation, identify risks and propose corrective actions;
  • Contribution to strategic decisions requiring regulatory input to minimize risks and ensure timelines for approval are optimal;
  • Participation in face to face authority meetings as appropriate;
  • Coordinate preparation of high-quality dossiers which fulfill regulatory requirements and competent authorities’ expectations;
  • Identify and ensure full visibility/transparency of perceived risks;
  • Provide effective support for pending procedures, be proactive with competent authorities to ensure that timelines for assessments are as short as feasible, ensure that content of responses are optimal and highlight any perceived risks;
  • Act as central contact point for all projects specific customers and ensure full visibility of project status, progress and issues;
  • Ensure that all activities fully comply with departmental and company SOPs and that all internal tracking tools and databases are maintained, accurate and complete.

Improve RA department work processes:

  • Identify needs for new SOPs/WIs to strengthen processes;
  • Lead implementation of these SOPs/WIs.

Regulatory Intelligence:

  • Keep up to date with European and national cosmetic regulatory trends, risks and opportunities for the business.

People Management:

  • Management of an Associate.

Qualifications

Do you have...?

  • Medicine/Veterinary/Sciences/Science degree, with pharmacy qualifications a plus;
  • Good knowledge of pharmaceutical & scientific processes;
  • Regulatory experience;
  • Experience and knowledge of the registration and post-market management of cosmetics and food supplements in the EMEA and other international markets;
  • Regulatory experience and expertise in non-medicine legislation, regulatory procedures and requirements;
  • Experience of people Management;
  • Commercial understanding of corporate and operational business issues;
  • Strong intellectual curiosity;
  • Excellent interpersonal skills.

Are you...?

  • Project leader;
  • Good communicator;
  • Able to work under pressure and to tight timelines;
  • Effective manager of your time;
  • Team player and able to collaborate;
  • Analytical (data rational);
  • Able to handle competing priorities effectively;
  • Results oriented, entrepreneurial and self-motivating;
  • Open to change and able to think out of the box.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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