Description
This is an exciting opportunity for a Regulatory Affairs Manager with a strong global pharma.The ideal candidate will
- Support and grow the business in line with the company goals
- Obtain and maintain marketing authorisations
- Ensure fast introduction of new products and line extensions including new indications
- Ensure regulatory compliance
- Streamline regulatory activities with other internal business partners to ensure efficient regulatory processes
- Contribute to influencing positive changes to the regulatory environment
- Coach junior colleagues on regulatory activities
- Lead the standardisation and creation of new systems and processes to ensure efficiency gains and to support business continuity
- Prepare and submit regulatory submissions with support as required from Regulatory Support Services
- Provide regulatory strategic input and status of submissions by participation in internal working groups to meet company objectives
- Monitor deadlines to ensure project deadlines are met or escalated to Head of RA
- Advise the Labelling Change & Quality Manager of any changes to labelling and packaging in line with current registered authorization details in order to maintain product compliance according to the relevant local and EU legislation
- Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP's & supporting systems)
- Maintain an awareness of regulatory guidelines/directives/national requirements in order to
provide appropriate advice to internal stakeholders and maintain appropriate knowledge levels within the team - Support other departments based on their needs by providing documentation and information in response to requests
- Contact local health authorities to resolve queries (general or product specific) when these cannot be addressed internally
- Support and contribute to GRA-EMEA initiatives as requested by Head of RA Contribute to local initiatives around lessons learnt and change management to ensure efficiency gains
Essential:
- Significant Regulatory Affairs experience at both operational and strategic level
- Direct experience and strong knowledge of general regulatory requirements and guidelines
- University Degree in Pharmacy, Biology, Chemistry or related Life Science Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists
If you are not currently looking but know of someone suitable that is, please do get in touch as we offer £200 in vouchers if your referral is successfully placed. Sthree UK is acting as an Employment Business in relation to this vacancy.