Regulatory Life Cycle Management Scientist
Job Details
Full Job Description
The GPS Global Regulatory Affairs Life Cycle Management Team based
at my clients site in Reading has a 1-year position available to build
Medicinal Product capability in and outside Europe.
We are
looking to hire a candidate strongly interested in Regulatory Affairs
- with experience in medicinal products. You will grow and maintain
major portfolio in particular for the European region, you will
coordinate changes to existing products/dossiers keeping them on the
market.
You will act as the point contact for our local
regulatory colleagues, who manage local market and authority
interactions, as well as with other technical & non-technical
functions like MPD, Product Supply,QA, Marketing and manufacturing
sites
Key Responsibilities:
*Build medicinal
capability within Regulatory Affairs Life Cycle Management and ensure
medicinal aspects are well reflected in projects, work processes, and
in our systems.
Business Use
*Enable PHC business for the
relevant portfolio within and outside Europe region by delivering to
time and to GPS SOPs on agreed and aligned priority base business
projects across each franchise & region, as well as on "LCM
initiatives" requiring changes to existing products/dossiers.
*Coordinate Regulatory Life Cycle Management activities
across multiple countries within and outside Europe.
oCoordinate
with Local Regulatory Affairs for variations, renewals and answering
health authority
requests.
oMaintain Global Master
Dossiers and compile, review, and provide dossiers for local
registration and compliance to achieve variations for the specific
product portfolio.
oAdvise organization of potential
regulatory risks in normal day to day activities and
recommend
compliant actions.
oEnsure regulatory
assessments are conducted for change controls in the respective Veeva
QualityTracking system.
oEnsure that the Veeva Regulatory
Information Management system is maintained and updated for all
activities under role responsibility, including review of documents.
oProvide strategic input into Regional Product labelling
and approval to enable commercial activation of product launches.
*Connect and synergy with all stakeholders related to the
responsible roles.
*Contribute to new regulatory policies,
systems and processes to reinforce governance and compliance across
LCM and the regulatory Affairs function.
Requirements:
Education: A minimum of a Masters' degree in pharmacy,
engineering, chemistry with knowledge in Regulatory
Affairs.
Languages: Proficiency in English.
Geography:
Ability to work permanently in country of residence
Job
Qualifications:
1.Professional with initial regulatory
affairs experience (1-2 years), preferably in consumer health and
preferably across multiple regulatory classification areas
2.Strong motivation for dossier maintenance and product
change management
3.Skilled in working with complex
Regulatory databases
4.Demonstrated ability to work
independently in a matrix environment to build superior relationships
with stakeholders
5.Strong initiative and follow-through
with accountability for work quality
6.Organisational
skills and solution-oriented attitude to handle a complex
product-country portfolio
7.Excellent attention to detail,
good communication and presentation skills
8.Results
oriented and self-motivating with an ability to influence others
9.Openness to change and ability to think out of the box
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
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Regulatory Life Cycle Management Scientist
Adecco
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