Regulatory Affairs Consultant

Recruiter
Hyper Recruitment Solutions Ltd
Location
West Midlands
Salary
£40 to £55
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
We are currently looking for a Regulatory Affairs Specialist to join a leading pharmaceutical company based in the Midlands. As the Regulatory Affairs Specialist you will be responsible for managing the product information and packaging for products prior to marketing approval.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Develop the regulatory strategy in conjunction with the clinical lead

2. Co-ordinate mock-up product information and packaging for products prior to marketing approval. For example, drafting the SmPC and PIL

3. Provide regulatory review and approval of marketing materials

4. Liaise directly with the EMA and similar regulator bodies

ROLE REQUIREMENTS:

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

1. Previous experience developing regulatory strategies

2. Proven industry experience in product information and packaging for products prior to marketing approval and co-ordinating changes to SmPC / Labels / Cartons for registered products.

3. Previous experience working with regulatory bodies such as the EMA.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.