Alexander Mann Solutions (AMS) is the world's leading provider of Talent Acquisition and Management Services. We deliver award-winning solutions to over 65 outsourcing clients and consulting services to hundreds more. Our Contingent Workforce Solutions (CWS) service acts as an extension of our clients' recruitment team and provides professional interim and temporary resources.
Our client is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, they transform scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare.
On behalf of this organisation, AMS are looking for a Regulatory Affairs Manager
covering maternity contract based in Reading.Purpose of the Role:
Manage regulatory activities for the defined category area according to business needs and GRA objectives.
Leads the coordination, preparation, submission and the follow up registration applications to the UK and /or Irish regulatory authorities, expeditiously and to high standards, to ensure that marketing authorizations are obtained and maintained in line with the company's plans and goals. Supports the launch of new products and life cycle management of the existing portfolio.As a Regulatory Affairs Manager you will be responsible for:
- Prepare or manage the preparation of marketing authorisation applications, to the highest possible standards within the agreed timeframe for submitting to the regulatory authorities.
- Prepare and submit, according to agreed timelines, the necessary documentation to the regulatory authorities to maintain and update existing marketing authorisations, to ensure continued development of existing products.
- Review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with current legislation and registered particulars and take action, to secure regulatory approval where necessary.
- Participate in the technical review and preparation of high quality regulatory submissions to the authorities within the agreed timelines.
- Assist more junior members of staff in developing their skills in the preparation of documentation for submission.
- Develop and maintain a comprehensive understanding of the regulatory requirements for medicinal products, food supplements and medical devices in the EU (specifically UK and Ireland) to enable regulatory submissions/documentation to be compiled in line with the current requirements.
What we require from the candidate:
- Communicate with supply chain to ensure regulatory strategy is implemented within agreed time-frames to achieve an uninterrupted supply of compliant product to the market.
- Establish and maintain effective liaison with the Medicines & Healthcare Products Regulatory Agency and /or the Irish HealthCare Products Regulatory Authority and other relevant personnel, including medical affairs, marketing, production, and research and development personnel, both within and outside the company, to facilitate expeditious registration.
- Develop an understanding of the commercial environment in the UK and contribute to commercial success through interactions and understanding of the Global Business Unit priorities. Champion the review and approve promotional and non-promotional materials ensuring their competitive position and compliance with local regulations, code of conduct and internal guidelines.
- Provide regulatory strategy during development, to support life-cycle management and commercial activities. Contribute and provide insight to GRA for innovation programs leading to innovative regulatory pathways to drive competitive positioning, maximize chances of approval and identify opportunities, regulatory risks and mitigation strategies. Inform line management and marketing teams of deviations from regulatory schedules which may affect marketing plans.
- Develop and maintain a good working relationship with internal and external stakeholders, at local, regional and global levels in line with One GRA Principles
- Concerning the Regulatory Environment, actively follow the development and emergence of new regulatory requirements and regulatory intelligence, ensuring that the appropriate impact assessment and company strategy are delivered to the relevant stakeholders
- Consumer healthcare background
- An in-depth working knowledge of licensing processes for marketing authorisations via national, mutual recognition, decentralised and centralised procedures, and submission to regulatory authorities.
- Good understanding of post-Brexit procedural routes to UK national marketing authorisation.
IR35 Status: This role has been assessed as inside of IR35 If you are interested in applying for this position and meet the criteria outlined above, please click the link to apply and we will contact you with an update in due course.
Alexander Mann Solutions, a Recruitment Process Outsourcing Company, may in the delivery of some of its services be deemed to operate as an Employment Agency or an Employment Business