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Regulatory Affairs Manager- Alvita - Woking, Surrey, United Kingdom - Alliance Healthcare
Description
About us:
Alliance Healthcare is a leading international provider of pharmaceutical wholesaling, logistics, support with clinical trials, and other innovative healthcare services and solutions to independent pharmacists and pharmaceutical manufacturers across Europe and beyond.
It is an exciting time for Alliance Healthcare as we have joined forces with Cencora.Cencora is a leading pharmaceutical solutions organisation centred on improving the lives of people and animals everywhere. With its comprehensive portfolio of end-to-end pharmaceutical commercialisation solutions, Cencora empowers patient-centred care worldwide. It ships 6.7 million products daily from 1,300 locations across an operational footprint in 50+ countries.
Cencora has an annual revenue of $238 billion, over 46,000 team members worldwide, is listed on the NYSE, and is ranked #11 on the Fortune 500This role will provide support to Alvita.
Alvita is Alliance Healthcare's label brand of competitively priced, high-quality patient care products.Alvita is Alliance Healthcare's brand of patient care products, with over 650 products covering medical devices, cosmetics and biocides, currently sold in 7 markets across Europe., with plans for further expansion.
This role requires an individual who can be flexible, deliver at pace, deal with ambiguity and demonstrate a strong capability for developing productive internal and external cross-functional working relationships.
This role will need to develop solid and productive working relationships with critical suppliers' regulatory and supply teams to facilitate the successful development of the Alvita range and delivery of the NPD Plans on budget.
Key Responsibilities:
You will manage the regulatory tasks in launching multiple NPD projects by the budget and 5-year growth plan.
You will support the Alvita European Brand Manager and Central Sourcing Team in assessing potential new products and supporting the evaluation of claims and product attributes of products offered by alternative suppliers.
You will be responsible for coordinating and managing artwork origination on projects, coordinating the artwork process with suppliers, legal manufacturers, design agencies and colleagues across the seven markets to deliver new products on the plan.
You will work collaboratively with the central and local teams to ensure the documentation on Alvita SharePoint is complete for all projects and organised to facilitate easy access to local in-market teams when asked to respond to requests for information from national competent authorities.
You will be responsible for becoming the subject matter expert on medical devices within the business and ensuring plans are in place to maintain compliance with the requirements of the Medical Devices Regulation (EU) 2017/745 and the in Vitro Diagnostic Medical Device Regulation (EU) 2017/746, in the context of our obligations as an own brand.
You will demonstrate an innovative approach to obtaining market intelligence from suppliers and other sources. This can support the brand and local commercial teams identify new product opportunities and develop long-term NPD plans.You will support the European Head of Regulatory Affairs and Pharmacovigilance in specific projects related to Alvita, including assessing the launch in new territories or the development of new processes necessary to deliver compliance with European and local legislation.
You will support the European Head of Pharmacovigilance and the European Head of Quality in developing the vigilance process for Alvita products.
You will collaborate with the Central Quality Team and colleagues to develop appropriate central and local procedures and working practices within the Alvita Quality Management System.
You will be key in the Monthly Operational NPD Meetings with the European Business units.Skills and Requirements:
You will be a self-starter with solid stakeholder management experience. You will have excellent communication skills at all levels.
You will be able to prioritise and organise workload and react to the changing needs of the business.
You will be able to persuade and influence internally and externally at various levels.
You will have an excellent working knowledge of Excel.
You will have experience working within the Medical Device and or Cosmetics Industry.
You will know appropriate European regulations and guidelines within the Medical Devices and Cosmetics Industry. Travel / Office Working It is estimated that the role requires less than 10% travel.
The candidate would be expected to work from the Surrey office 2 – 3 days per week.
What we'll do with your data:
We will hold your information for as long as the position you have applied to is open and for up to 3 months.
Please let us know if you wish us to delete your personal information before this.Our vision is to build a culture where diversity, equality, and inclusion are central to everything we do, powering more outstanding teamwork and innovation and inspiring us to help people worldwide lead happier, healthier lives.
We are an equal opportunities employer on a mission to attract, develop and engage employees who reflect the diverse customers, patients, and communities we serve, and to foster an inclusive culture where everyone feels respected, valued, and excited to drive superior business performance.
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