Reference Number: JO-2004-448685
Regulatory Affairs Specialist
Job Type: Permanent
Role: Regulatory Affairs Specialist
Employment: Permanent, Full Time
Our client is a global pharmaceutical company who offer a range of medical solutions and consumer products, focusing on science-based solutions that will enhance the quality of people’s lives. In this role you will responsible for maintaining marketing authorisations for assigned products for both the UK and Ireland and dealing with life cycle management activities.
Offer regulatory advice for new and existing products.
Life cycle management activities for existing marketing authorisations (National & MRP/DCP) in the UK and Ireland.
Assist in compiling (Module 1 Documents) for new marketing authorisation applications for both the UK and Ireland.
Establish Regulatory Affairs priorities, budgets and allocate resources appropriately.
Manage audits, inspections, recalls and Pharmacovigilance activity relating to Regulatory Affairs.
Interconnect Regulatory information to internal stakeholders (at UK or Global) to ensure information is interpreted correctly and timelines met for regulatory submissions.
Co-ordinate artwork amendments and tracking of packaging modifications by liaising directly with marketing, regulatory affairs, packaging, manufacturing and/or third parties as appropriate.
Prepare, submit and follow up applications for export certificates to the MHRA and/or HPRA.
Compile maintain and work according to standard operating procedures, which are in accordance with current legislation and global procedures.
Accumulate information in line with company guidelines to ensure effective retrieval (both electronic & paper filing).
Sustain awareness of existing and new legislation/ guidance and ensuring that colleagues and the business are aware of any changes and potential impacts
Undertake ad-hoc regulatory duties from time to time as may be reasonably required by the company; for example contributing to regional and global regulatory strategy
Knowledge, Experience & Skills:
Degree level education in a Life Science discipline (or equivalent).
At least 3-5 years experience of regulatory (post approval/post marketing/life cycle management) within the pharmaceutical industry in the UK/Ireland covering ethical medicines (POM & OTC)
Key Skills / Experience Required:
High level of accountability and a can-do attitude
Excellent attention to detail
Proven experience within Regulatory
Strong scientific background
Proven effective communication skills
Proven customer service/relationship management skills
Proven project management skills
If you are interested in discussing this role further, then please email your CV to firstname.lastname@example.org or call Amani on 01189 522 797 to arrange a confidential discussion.
If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*.