Regulatory Affairs Manager

Genpact Pharmalink
02 Dec 2017
05 Jan 2018
Contract Type
Full Time
Regulatory Affairs Manager

Contract: Full Time Permanent

Ref: GPRAM1117

Location: Belfast (opportunity to work offsite 2-3 days a week)

Salary: Competitive + benefits, pension, healthcare, life assurance.

Hours: 40 hours per week (Monday - Friday)

Genpact Pharmalink Consulting is a highly specialised Regulatory Affairs Consultancy with a successful history spanning over 19 years. We have grown and developed our service offering, through building relationships, listening to our clients' needs, and adapting our ways of working to meet the changing needs of regulatory markets around the world. It is this flexibility and adaptability that we look for in all of our employees, which will allow us to continue to provide the level of service our clients have come to expect from Genpact Pharmalink Consulting.

We currently have an exciting opportunity for an experienced Regulatory Affairs Manager to join our Belfast division. The majority of this role can be carried out remotely but will require a minimum 2 days per week spend on site in Belfast City Centre. Candidates will work on various projects with exposure to some of the world's biggest pharmaceutical companies.

Our ideal employee would have:

- Minimum of 5 years working experience in the pharmaceutical regulatory affairs area and in particular in the EU regulatory framework;
- Deep knowledge of the procedural details of EU regulatory submissions (e.g. variations, renewals, line extensions, initial Marketing Authorization Applications, PSURs, referrals, Marketing Authorization Holder transfer);
- Working experience in the EU linguistic review process for Centralized Products, implementation QRD conventions and standard terms;
- Mastering of regulatory document management systems (metadata, workflows, approval and distribution);
- Solid knowledge of Microsoft Office applications (Word, Excel, Outlook)

"We are an equal opportunities employer and we welcome applications from all suitably qualified persons regardless of their sex; religious or similar philosophical belief; political opinion; race; age; sexual orientation; or, whether they are married or are in a civil partnership; or, whether they are disabled; or whether they have undergone, are undergoing or intend to undergo gender reassignment."