Company: Pharmalink Consulting
Closing Date: 15 Dec 16
Salary (£): Competitive
Genpact Pharmlink is a highly specialized Regulatory Affairs Consultancy with a successful history. 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 Consultants.
Regulatory Associate/Consultant (Immediate start)
We are looking for Associate/Consultant level that is available to join Genpact Pharmalink and the team immediately on an initial 3 month fast moving project. We are looking for a candidate with a good understanding of CMC including Module 3 experience (Compliance work, remediation work (variations, renewals etc.)). Ideally looking for someone with Documentum experience.
Your duties as a regulatory affairs team representative may include but not limited to:
· Defining CMC regulatory strategy for applications across the product lifecycle and all regions as necessary
· Dossier Preparation and authoring including core Module 2, Module 3, and redaction authoring as appropriate, for all submissions including: o Clinical trial and MAAs o License renewals, variations, CT amendments, site registrations etc.
· Providing CMC intelligence and registration requirements to support CMC, biosimilars and device strategy across the product lifecycle and across all Client regions and territories as requested
· Managing the various stages of a project lifecycle: initiation, monitoring, management, escalation, closing.
· Assist in the development of global regulatory strategy and update strategy based upon regulatory changes
As a minimum, you should have:
· Proven experience in Regulatory Affairs
· A life sciences BSc or equivalent qualification
· Excellent verbal, written and organizational skills
· Be able to manage multiple priorities and projects and deadlines
· Be team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity working environment.
Vanwall Business Park
|Tel:||+44 (0) 1628 860300|
|Fax:||+44 (0) 1628 860400|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.