Regulatory Affairs Manager

North West
13 Jun 2018
11 Jul 2018
Georgia Walden
Contract Type
Full Time
An interesting opportunity has become available for a Regulatory Affairs Manager experienced in Generic Pharmaceutical New Product Licensing to join a leading Pharmaceutical company based in the North West. As the Regulatory Affairs Manager you will be responsible for the Project Management of Regulatory strategy for the licensing of Generic Inhalation products.


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

1. Responsible for the regulatory input for the contribution to product development and regulatory strategy planning.

2. Author and edit regulatory submission documents for new product licensing including Modules 1, 2 and 3, with a focus on CMC documentation.

3. You will also coordinate, prepare and be accountable for submitting and monitoring of MAA (Marketing Authorisation Applications).

4. You will liaise with Regulatory agencies within the EU for MRP / DCP submissions as well as US authorities for NDA submission.


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

1. Relevant degree in a Scientific discipline (e.g. Chemistry, Pharmacology, Pharmacy etc.) in addition to extensive experience with a Regulatory Affairs setting.

2. Proven industry experience in a Pharmaceutical Industry where you are directly dealing with regulatory agencies in the EU (US is also desirable).

3. A working knowledge and practical experience with New Product Submissions for Generics, ideally with knowledge of Inhalation dosage forms. A focus on CMC activity and Documentation will be highly beneficial for your application.

Key Words: Regulatory Affairs , Project Management , Pharmaceutical , Generics , Inhalation , CMC , Module 3 , New Product Submissions , eCTD , MAA , EMA , MHRA , FDA , Regulatory Strategy

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.