Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer
Role type: Permanent
Salary up to £60,000DOE

Sector: Pharmaceuticals
Job Location: Hampshire, London or Yorkhire.

We are assisting our client in their search for a Senior Regulatory Affairs Officer. This is the ideal role if you want to contribute to the success of a firm over many years to come.
We’re looking for someone who can be hands on and lead a small team. If you want a pivotal role and want long term employment and match these requirements we’d like to hear from you.
The client currently has a relatively flat management structure offering you the perfect opportunity for personal development and promotion.

This is a hands’ on position involving submissions for new registrations. These include change of ownership, licence acquisitions, licence renewals and site transfers. You would report to the Head of Technical Operations and Regulatory Affairs and work closely with Third Party Manufacturers as well as internal departments (Commercial and QA) and third party service providers.
If you have good communications skills then this will be to your advantage.

Can you work under minimal supervision and meet tight deadlines? If so, then this could be the dream role for you.

This role will include:
Production and review of Design Dossiers, Technical Files and Product Master Files

Preparation of regulatory submissions for product approvals/registrations

Communicating with outside agencies/regulatory bodies

Technical transfers

Handling Type I and Type II variations

You will love this role if you have:
Substantial regulatory experience in generic pharma

A history of performing variations such as; Type I (all forms), Type II, PIQ & writing the technical aspects of the variations.
Some experience of technical transfers

Performance of CTD / e-CTD submissions

Experience of project management (workload planning)

Line Management experience would be an advantage

Degree in a life science

Knowledge/experience of the requirements of GMP (Directives 2001/83/EC and amendments)

Ideally you will possess:
Excellent attention to detail

Microsoft Word and Excel experience

Excellent communication and interpersonal skills

Ability to take responsibility for overcoming challenges to ensure projects continue to progress in a timely manner

Experience of managing a team

MAC Scientific and our clients are an equal opportunity employers and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.