REGULATORY AFFAIRS ASSOCIATE DIRECTOR (CONSULTING)

REGULATORY AFFAIRS ASSOCIATE DIRECTOR, EUROPEAN and NORTH AMERICA REGULATORY AFFAIRS

Our client is a small but established Pharmaceutical consultancy offering a range of services to the industry. Make no mistake, this is not a CRO and neither has the pressures that comes with working in such an environment. you will be joining a small but proven Regulatory department and play a viotal role in its future growth. This could be expanding the Biotech, Pharma or Medical Device Unit.

As a Regulatory Affairs Associate Director you will work on individual projects or as part of a project team. This role will interface with clients to provide specific regulatory consultancy as well as having an operational role in the preparation of documents, reports or regulatory submissions.

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 Fulcrum operations (clinical research, Pharmacovigilance, data management).

Preparation of regulatory documents and associated dossiers.

Regulatory submissions in Europe and North America, as well as some other regions

Review of documents and applications prepared by clients or by other consultants within or on behalf of the Company.

- Regulatory awareness searching and communication of intelligence within the Company.

The ideal candidate:

SUBSTANTIAL Regulatory experience, proven consultancy background

Experience of Centralised, Decentralised, 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).

For more information regarding this position please contact the Senior Consultant Abid Kanji on 0207 940 2108 or email him at [Email caché]