job details for:
Regulatory Affairs - Senior Regulatory Affairs Consultant Jobs - Hertfordshire

Regulatory Affairs - Senior Regulatory Affairs Consultant Jobs - Hertfordshire (Job Ref: WR/JOBS/24838-11323)

Job Description :

Flame Pharma Regulatory Affairs – Senior Regulatory Affairs Consultant Job - Hertfordshire:

Job Summary

Hertfordshire, UK:  Salary upto £90k

Flame Pharma is working alongside a global pharmaceutical and regulatory services organisation in appointing a strategic regulatory affairs expert for their state of the art facilities in Hertfordshire.  As a worldwide organisation with expertise in UK, Europe, USA and Japan, this newly created opportunity will contribute to the vision, strategy and business performance of this critical operation.  The Senior Regulatory Affairs Consultant would be responsible for projects within the areas of regulatory affairs concerned with biological and biotechnology products, pharmaceuticals and medical devices but could also involve other areas such as veterinary products, and drug delivery systems.  This exceptional opportunity would require the very best within the Regulatory Affairs sector, and a result, the salary, benefits package and autonomous working environment is reflective of this.

The Role

Working alongside the Director of Regulatory Strategy, you will be considered an expert for the company on regulatory affairs issues, and will provide advice on regulatory and development strategy and undertake regulatory Due Diligence reviews of potential product acquisitions on behalf of clients.  You will provide evaluation of data and preparation of “gap analysis” reports, plus Project co-ordination or project management of client projects, including tracking of project time and costs against contract deliverables and budgets.  In addition to overseeing preparation of regulatory documents and associated dossiers and Regulatory submissions in Europe and North America, you will provide support for Company business development activities on an international basis.

The Person

You will be a senior regulatory affairs professional, ideally an associate director or director with experience in a Pharmaceutical, Clinical Research, Biotechnology, company or regulatory consultancy.  You will have extensive knowledge of drug development, including development planning, evaluating development programmes and data requirements.  In your current or previous positions, you will have experience of Centralised, Mutual Recognition and National Marketing Authorisation (MA) applications in Europe.  You will also have experience in Chemistry, Manufacturing and Control (CMC), non-clinical and clinical documentation, plus clinical trial authorisation applications across Europe (CTA, Clinical Trial Directive) and North America (US and Canadian IND etc).

Key Words

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

For further information about this role, please contact Flame Pharma.