job details for:
Regulatory Affairs - Associate Director of Regulatory Affairs Jobs - Hertfordshire

Regulatory Affairs - Associate Director of Regulatory Affairs Jobs - Hertfordshire (Job Ref: WR/JOBS/24860-11345)

Job Description :

Flame Pharma - Regulatory Affairs – Associate Director of Regulatory Affairs Job - Hertfordshire:

Job Summary

Flame Pharma is proud to be working alongside an innovative, world leading drug development and regulatory services organisation in recruiting the Senior Regulatory Affairs Consultant for their Hertfordshire offices.  This senior role, together with the Director of Regulatory Strategy, will act as a primary interface with Regulatory clients for project management as well as providing specific regulatory consultancy.  In addition the Senior Regulatory Affairs Consultant will have an operational role in the preparation of documents, reports or regulatory submissions for particular projects within the project team.

As a worldwide organisation with expertise in Europe, USA and Japan, they can offer the right candidate with extensive experience within regulatory affairs the opportunity to take their career to the next level.  So, if you are a Senior Regulatory Affairs Consultant, an Associate Director or Director of Regulatory Affairs, then please contact Flame Pharma for a confidential discussion.

Job Title

Associate Director of Regulatory Affairs

Background

Our client provides regulatory affairs and regulatory compliance consultancy services to an international client base of companies in the area of biological and biotechnology products, pharmaceuticals, medical devices and related products.  They provide both strategic and operational regulatory support across the whole drug development value chain. 

Regulatory affairs and related consultancy services are delivered globally, and the objective of the current recruitment is to expand it’s team of experienced individuals offering strategic regulatory input under the leadership of the Director of Regulatory Strategy and to complement the existing operational activities available within the group.

Key Responsibilities

Project activities will vary but could include any of the following:

• Evaluation of data and preparation of “gap analysis” reports.
• Advice on regulatory requirements.
• Advice on regulatory and development strategy.
• Preparation of development plans for client products.
• Participation in client project teams.
• Project co-ordination or project management of client projects, including tracking of project time and costs against contract deliverables and budgets.
• Undertaking regulatory Due Diligence reviews of potential product acquisitions on behalf of clients.
• Regulatory support for other company operations (clinical research, pharmacovigilance, data management).
• Preparation of regulatory documents and associated dossiers.
• Regulatory submissions in Europe and North America.
• Review of documents and applications prepared by clients or by other consultants within or on behalf of the Company.
• Liaison with clients regarding ongoing projects.
• Liaison with regulatory authorities.
• Regulatory awareness searching and communication of intelligence within the Company.
• Providing support for Company business development activities as required (e.g. attending meetings with potential clients, input into project proposals).

Qualifications and Experience

• Extensive regulatory affairs experience, preferably gained in a pharmaceutical or biotechnology Company, a regulatory affairs consultancy or a regulatory agency.  The length, breadth and depth of relevant experience will define the level of the role.  There is no maximum level of experience.
• Experience of drug development, including development planning, evaluating development programmes and data requirements.
• Experience of Centralised, Mutual Recognition and National Marketing Authorisation (MA) applications in Europe.
• Experience of MA life cycle management (variations, renewals, labelling, line extensions and generic competition strategy).
• Experience with other regions is an advantage (e.g. USA, Japan, global development).
• Experience of Chemistry, Manufacturing and Control, non-clinical and clinical documentation.
• Experience of clinical trial authorisation applications across Europe (CTA, Clinical Trial Directive) and North America (US and Canadian IND etc).
• Experience of Orphan Drug Designation applications, Scientific Advice procedures, pricing and reimbursement submissions and strategies are advantageous.

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary up to £90k

Key Words

Regulatory Affairs, Senior Regulatory Affairs Consultant, Regulatory Affairs Director, Senior Regulatory Affairs Manager, Pharmacovigilance, Drug Safety, Director, Manager, Management, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Hertfordshire, Job, Recruitment

The position will be based in Hertfordshire.

For further information about this role, please contact Flame Pharma on 0800 085 0858.