Loading...
Share this Job

Regulatory Affairs Manager - Cosmetics (non-medicines) - 12m FTC

Date: Oct 15, 2021

Location: Harlow, GB, CM20 2FB

Company: Teva Pharmaceuticals

Who We Are

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

 

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

 

What do we offer you?

 

  • 12 months Fixed Term Contract
  • 25 days annual leave plus Bank Holidays
  • Flexible benefits including health insurance, life assurance, critical illness insurance, gym-flex and cycle to work scheme
  • Programme of Well-being initiatives including on-site Creative Rooms, Employee Assistance Programme, Wellbeing Champions

Function

Regulatory Affairs

Reports To

Associate Director or Senior Manager, Non-Medicines Regulatory Affairs

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.