ProClinical is seeking a Regulatory Affairs Associate for an international health ingredients manufacturer and a world leader in the development and marketing of pharmaceuticals and food products the RA associate role will deal with post-licensing regulatory activities associated with ensuring marketed products are in compliance with applicable legislation and business requirements. This is a permanent position based in Scotland.
- Compliance with relevant regulatory legislation and guidelines.
- Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice
- Co-ordination of the regulatory activities associated with project team plans
- Preparation, attendance and follow up of meetings with Regulatory Agencies (e.g. requests for scientific advice on defined projects, including the generation of briefing documents and minutes
- Production of regulatory submissions, including applications for marketing authorisations, ready for publishing.
- Co-ordinate the provision of information requested by regulatory authorities
- Co-ordinate communication between Post-Licensing Regulatory Affairs, regulatory authorities, licensing partners and affiliate regulatory affairs contracts.
- Acting on new safety information received, as appropriate, in a timely manner
- Personal development and training
- Review and approval, submission of regulatory submissions (e.g. marketing authorisation applications, responses to regulatory authority questions, lifecycle submissions) within timelines agreed with management or defined by legislation: monitoring and facilitation of progress.
- Co-ordinate activities required to provide information requested by regulatory authorities.
- Co-ordinate and approval (and distribution as appropriate) of core regulatory documents e.g. SmPC, Label and Patient information leaflet.
- Record Keeping: maintenance of paper and electronic records of all submissions and communications with regulatory authorities, and any supporting documentation
- Provision of expert regulatory advice to other departments in the organisation
- Provision of regulatory support to licensing partners in the EU and ether territories.
- Assist with the preparation of essential regulatory processes incorporated into and controlled by the assurance system
- Communication of changes in business-critical legislation /regulatory guidance, and project and product regulatory status to appropriate internal and external personnel in a timely manner highlighting the implications of the changes.
Skills and Requirements:
- Life science qualification with a minimum of 3 years' experience in regulatory affairs in the pharmaceutical industry
- Good regulatory knowledge
- Excellent negotiation, verbal and written communication and interpersonal skills
- Good analytical and problem-solving skills
- Good organizational and project management skills and attention to detail
- Ability to understand and present scientific arguments
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.