Milton Park Jobs - vacancies
Senior
Regulatory affairs Manager
We
are looking for a Senior Regulatory affairs Manager to work out of
the new office in
Cambridge
and
support the business with local clients there.
Reporting to the Regulatory Affairs Group Manager, you will
function as a senior member of the Regulatory Affairs Department
deputizing for the function head as required, providing high level
scientific and technical advisory support services to clients of the
company on matters concerned with the development and regulatory
authority approval for marketing of medicinal products and devices.
As a senior member of Constella’s professional staff, you will
develop and maintain familiarity
with current industry practices that affect regulatory
affairs in general; disseminate relevant information and
intelligence to company personnel; assist and lead in the design and
implementation of various high value solutions for clients, perform
technical leadership and oversight to the project team in the area
of regulatory affairs,
assume role of project team representative and leader, and assist in
the development and implementation of training; serve as an active
mentor to one or more junior staff members and provide training as
requested by the functional leader.
If assigned direct reports, you will schedule and review
project tasks; provide leadership in the delivery of services to
clients; ensure staff fulfil their responsibilities in accordance
with Constella’s policies, procedures and SOP’s, and ensure HR
processes are properly implemented.
To be successful in this role, you will need to demonstrate a
minimum of six years of employment related experience in regulatory
affairs, a minimum of six years experience dealing with regulatory
authorities in Europe or with the FDA, hold demonstrated project
leadership/ managerial skills, and demonstrable skill in using
computerised information systems, alongside a Life Science degree,
pharmacy degree, medical or veterinary degree
To
apply please send your CV to: recruituk@constellagroup.com