Head of Regulatory Affairs

Location
Wiltshire
Salary
Dependent on experience
Posted
16 Feb 2021
Closes
18 Mar 2021
Ref
J5634484
Contact
Debra Fong
Contract Type
Permanent
Hours
Full Time
Are you an experienced Head of Regulatory Affairs or Regulatory Affairs Manager looking for an exciting new opportunity?

We are currently looking for a Head of Regulatory Affairs to join a leading biopharmaceutical company based in the Wiltshire area.

As the Head of Regulatory Affairs you will be responsible for leading, managing and directing all aspects of Regulatory Affairs. You will also play a key role in support the Regulatory Affairs team members in the evaluation of marketing authorisation applications, variations and other regulatory submissions.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Head of Regulatory Affairs will be varied however the key duties and responsibilities are as follows:

1. You will be responsible for the management of a small team which may include recruiting into the team, job description preparation, professional development, goal setting, performance management, technical coaching and mentoring. You will be working closely with the Director of Regulatory Affairs and Pharmacovigilance as well as other cross functional and department management when required.

2. You will also be responsible for establishing and agreeing an annual income and expenditure budget for a defined project / programme area and ensure that all projects operate within budget, timescales etc. Additionally, support / co-ordinate commercial negotiations with customers to achieve project objectives, secure optimal cost recovery and protect intellectual property in accordance with the company's requirements.

3. As the Head of Regulatory Affairs, you will manage and maintain regulatory licences and approvals relating to manufacture, testing and distribution of medicinal products by the company and be the point of contract for regulatory authorities, customers, UK Government Departments on regulatory affairs as appropriate.

4. You will be required to contribute to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing regulatory focused analysis and guidance on all activities, plans, targets and business drivers as well as contribute to the development and implementation of global/regional function/plans.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Head of Regulatory Affairs we are looking to identify the following on your profile and past history:

1. Relevant Life Sciences degree and an understanding of the key strategic regulatory challenges aims for department, e.g. financial management of costs and risks associated with licenses biologic pharmaceuticals; the commercialisation process for biologic products; challenges associated with manufacturing scale-up / clinical trials is essential for this position.

2. Proven industry experience of preparations of marketing authorisations and / or clinical trial applications, preparation of formal responses to regulatory authorities and pharmaceutical licensing procedures in the UK, EU and USA are also requirements for the role of Head of Regulatory Affairs.

3. Knowledge of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management; superior understanding of ICH and other global regulatory guidelines; advanced knowledge of at least one of the regulatory speciality areas: preclinical, clinical, CMC, publishing, etc is required.

Key Words: Head of Regulatory Affairs | RA | Quality Assurance | Pharmaceutical | Biopharmaceutical | Life Science | CMC | GMP | Medicines | TOPRA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.


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