Regulatory Affairs Manager

Negotiable
  1. Permanent
Tring, Hertfordshire
  1. Regulatory Affairs, CMC
Posted: 23/03/2021
BBBH16183

This vacancy has now expired. Please see similar roles below...

Hobson Prior currently have an exciting permanent opportunity for a Regulatory Affairs Manager to join a global leader within health and wellness.

This position can be in either London or Tring with 1-2 working from home however please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

  • Accountable for all aspects of in market regulatory compliance for defined projects, brands and/ or portfolio including, but not limited to, new and existing products, packaging and communications.
  • Ensuring regulatory operations are adequately briefed & resource is secured for all projects.
  • Supports innovation/ new product development and renovation of existing products through, amongst others, review of product ideations; formula and raw material compliance review and assessment; development of new and review of existing claims: label development, review and approval; sales and marketing collateral including advertising, point of sale and web copy; registrations or licencing applications.
  • Provide training and support on regional/franchise/subject matter specialities to operations team to ensure effective compliant delivery of all operational tasks.
  • Ensures change controls are reviewed, approved and implemented within required timelines to maintain compliance.
  • Demonstrates expert understanding of all applicable Regulations, guidance and industry best practice and partners with internal stakeholders proactively to create and implement strategies to comply.
  • Manages Regulatory Agency and submissions, as required e.g. FDA 30 Day Notification Letters.
  • Horizon scanning: Monitor the industry landscape with a particular focus on new regulations and relevant litigation.
  • Follows Safety, Health, and Environmental policies and procedures.
  • Provides leadership and training to direct reports and peers, as relevant and when required, and works to maximise their skills and potential.
  • Other projects and duties as required/assigned.

Key Skills:

  • Pro-active, creative, forward-thinker with the ability to think innovatively about integrated strategies for regulatory affairs while accurately anticipating future consequences and trends.
  • In an environment where developing and introducing new products quickly and effectively is a key driver of competitive advantage.
  • Acts to surpass goals, seizing opportunities to push the envelope. Communicates direction or changes with clear rationale and appeal. Advocates for the new direction, and takes it onboard personally, even countering conventional practice.
  • Create Possibilities From New Thinking, Generate Disruptive Change, Lead Change.

Requirements:

  • Minimum of 5+ years' experience in a regulatory affairs role.
  • Solid understanding of the consumer healthcare/nutraceutical industry landscape and market trends.
  • Proven ability to build regulatory processes and systems. Quality experience/background is a plus.
  • Strong track record and technically savvy in the Regulatory Affairs function, able to provide expertise and guidance on product submissions with global health authorities.
  • Experience working with R&D and cross-functional teams desired.
  • Bachelor degree required; Advanced degree desirable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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