Regulatory Affairs Manager

An excellent opportunity for a talented, independent and self-motivated regulatory professional to join a team that will not only provide you with a wide variety of experience in regulatory projects, it will also give you all the support you need to develop your regulatory career. You will work directly with clients, handling tasks with minimum supervision and interacting professionally at multiple levels within client organisations.

Job Responsibilities

• Exposure to a wide variety of regulatory projects providing strategic advice to optimise regulatory pathways for clients
• Supporting the preparation of regulatory documentation including ODD, PRIME, CTA, Ethics and MA applications
• Providing support to clients in technical dossier requirements and compiling modules of the CTD for various product developments
• Forging strong relationships with clients and regulatory agencies through scientific advice meetings and agency negotiations
• Being part of a small, high performing team, you will be involved in mentoring other team members on key projects
• The opportunity to play a part in growing and enhancing the strong reputation the company already has in the regulatory industry.

Skills and Requirements

• Life Sciences Graduate or Pharmacist, ideally with a post-graduate qualification
• At least 3-4 years' experience in the medicines industry
• Experience in writing EU regulatory documents with sound knowledge of the EU medicines Directive associated guidelines
• Proven capability in working on multiple projects and effectively managing time to meeting critical timelines
• Able to demonstrate effective communication skills in dealing with diverse group of stakeholders
• A willingness to support resolving complex issues and driven to deliver results
• Good organisational and analytical skills with the flexibility to work across multiple client projects, with excellent attention to detail
• You will be expected to work independently on a day-to-day basis, whilst integrating into team project work.
• A proactive approach with a hands on, can do attitude required for a small team.
• Fluent in written and spoken English.

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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