Regulatory Affairs Manager
- Regulatory Affairs
Regulatory Affairs Manager - Permanent
Extremely Competitive salary and benefits package
Reference number: JO-1812-421014
An incredible opportunity for a Regulatory Affairs manager has arisen to join a market leading Pharmaceutical company providing medical solutions within Dermatology, with a huge dominance and success rate within this sector.
Coming from a strong Regulatory background, your core deliverables will be:
-Ensure compliance to company policies and procedures with respect to Regulatory Affairs., including regular collaboration with EMEA counterparts.
-Assist in compiling (Module 1 Documents) for new marketing authorisation applications for both the UK and Ireland.
-Maintaining marketing authorisations for assigned products for both the UK and Ireland to meet regulatory requirements.
-Prepare, submit and follow up applications for export certificates to the MHRA and/or HPRA.
-A strong sense of business partnering, with proven communication and customer service/relationship management skills.
-To support and develop junior regulatory team members
-To store information in line with company guidelines to ensure effective retrieval (both electronic & paper filing).
-Co-ordinate artwork amendments and track packaging modifications by liaising directly with marketing, regulatory affairs, packaging, manufacturing within the business and/or third parties as appropriate.
-Maintain awareness of existing and new legislation/ guidance and ensuring that colleagues and the business are aware of any changes and potential impacts
As a successful applicant, you must have:
-A degree level education in a Life Science discipline
-At least 3 years experience of regulatory (post approval/post marketing/life cycle management) within the pharmaceutical industry in the UK/Ireland covering both POM & OTC medicines. This includes interfacing with MHRA and HPRA.
-Experience of working in Quality / CMC related areas
If this role is of interest to you, and you would like to have a confidential more in depth chat regarding the position then please give me a call on 01189522797.
Alternatively, feel free to email me your CV to firstname.lastname@example.org for immediate consideration.
If this role is not quite right, no worries at all. If youre interested in hearing about other great career opportunities, then please still get in touch as there are numerous Regulatory requirements at the moment. Additionally, if you know someone that may be interested in this role then we reward 250 worth of vouchers for every successful placement so please let me know!