Location: Weybridge/ Hybrid

Salary: Competitive Plus Bonus Plus Pensions

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 recently joined forces with AmerisourceBergen. We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked#8 on the Fortune 500.

We have an essential role in the medical supply chain, and everything that we do as a company will ultimately impact the end-user, the patient. Our responsibility is to offer a reliable service that ensures that our customers receive the right product, in the right place, at the right time.

Almus and Alvita are Alliance Healthcare brands. Almus is a fast-growing innovative range of generic medicines that offers approximately 450 products and is available in three European markets.

Alvita is a range of over 700 healthcare products such as medical devices, toiletries, and biocides. Alvita products are available across seven different markets.

About the Role:

As a Regulatory Affairs Manager for Almus and Alvita, you will work in collaboration with the European Head of Regulatory Affairs, central team, and in-market teams. You will manage the regulatory activities supporting the brands’ businesses and products in accordance with budgeted new product development and resourcing plans. Under the direction of the European Head of Regulatory Affairs, you will also manage the submission of European Procedures, coordinating all the necessary variations to the process. You will be responsible for performing a variety of regulatory tasks in relation to pharmaceutical and personal care products and for providing functional support to regulatory teams in the market.

Key Responsibilities:

• Perform regulatory tasks to support the launch of new Almus and Alvita products as part of a multifunctional team, in accordance with Budget and 3-year plans.

• Manage the preparation and submission of the Mutual Recognition Procedure and Decentralised Procedure (DCP) Marketing Authorisation Applications (MAAs), involving more than one Almus market.

• Co-ordinate the management of all variations with suppliers and local regulatory teams for European Procedures involving more than one Almus market; ensure that all marketing authorisations and products meet necessary legal compliance.

• Manage the preparation and maintenance of Regulatory Compliance Files with the local affiliates and suppliers for European Procedures involving more than one Almus market.

• Manage the regulatory information within Samarind RMS for European procedures, involving more than one Almus market. Develop the “Subject Matter Expertise” on the use of Samarind.

• Contribute to the successful implementation of Identification of Medicinal Products (IDMP) standards into the IT tools and business processes.

• Assess the regulatory requirements for new products to be included in the Alvita range ensuring the product and its labelling are legally compliant.

• Prepare and review Product Specifications and Artwork Management Sheets, supporting the launch of new Alvita products.

• Support the development of appropriate global as well as local standard operating practices and working practices, to optimise the effective handling of regulatory tasks related to Almus and Alvita.

About you:

Skills:

• Good communicator, both orally and in written form. Good interpersonal skills with proven ability to manage a multifunctional team. A self-motivated dynamic individual, with the ability and desire to work proactively. Ability to prioritise and organise workload Ability to interpret legislation and evaluate the impact on the business.

Experience:

• Experience in working within European Regulatory Affairs team, supporting pharmaceutical products and medical devices. Competent in managing European Procedures (MRP/DCPs). Experience in submitting new MAA’s for European procedures. Experience with medical devices legislation and working on medical device products. Good working knowledge of pharmaceutical legislation.  Fluent in English   Additional language will be advantageous.

Minimal travel - meetings with local regulatory teams may be required.

What we offer

You will have an opportunity to grow your career in one of the leading UK pharmaceutical wholesale companies. You will join a friendly professional team dedicated to growing the business. We offer a competitive salary and an attractive bonus scheme.

What we’ll do with your data

We’ll hold your information for as long as the position you have applied to is open and for a period of up to 3 months after. Should you wish that we delete your personal information before this, please let us know.

Alliance Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Our vision is to build a culture where diversity, equality, and inclusion are at the centre of everything we do, powering more outstanding teamwork and innovation and inspiring us to help people across the world 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.