Regulatory Affairs Manager

Regulatory Affairs Manager at Alliance Healthcare

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This role is in support of Almus & Alvita, a Cencora business offering a trusted source of generic pharmaceuticals and a line of quality healthcare products in Europe.

We are looking for a skilled Regulatory Affairs Manager to join our Commercial Affairs team. This is a hybrid position that requires working 3 days in the office, while offering the flexibility to work 2 days from home.

Alvita is a range of healthcare products, (medical devices, toiletries and biocides etc.) which includes over 700 Alvita products marketed in 7 markets, with plans for further potential expansion. The Alvita brand has been identified as a key company growth initiative, with a 5‑year plan targeting 2.5× growth of current revenue and doubling of profit. Over half of the targeted growth will come from New Product Development (NPD) launches.

This role will be integral in delivering the NPD required to support the growth plan.

Almus is the generic brand of medicines which includes over 800 products marketed in 4 countries. An Almus entity is either the marketing authorisation holder, Exploitant or own‑label distributor depending upon the market. The Almus range is supplied by over 35 suppliers located in over 20 different countries.

This senior role sits within the Central Regulatory Team and will work closely with other colleagues within Commercial Affairs;
Quality, Sourcing and Supply Chain and local teams in market as well as with suppliers of Alvita and Almus branded products.

To lead and manage the regulatory activities supporting the own‑brand ranges sold through the Pharmaceutical wholesale business (Alliance Healthcare) which is part of the Cencora Group, in accordance with budgeted NPD and resourcing plans.

To work in collaboration with the European Head of Regulatory Affairs and Pharmacovigilance, Central team and in‑market teams, in development and extension of the Alvita product range across the UK and continental Europe and into new potential markets in accordance with the agreed budget and 5‑year growth plan.

This role will be responsible for leading and performing a variety of regulatory tasks in relation to pharmaceutical and personal care products and in addition provide functional support to regulatory teams in market.

Under the leadership of the European Head of Regulatory Affairs and Pharmacovigilance, this role will be responsible for managing the submission and coordinating the necessary variations of European Procedures, involving multiple markets.

This role is pivotal in supporting the development and regulatory maintenance of the Alvita and Almus ranges and potential expansion into new markets, ensuring the own‑brand products owned by Alliance Healthcare are legally compliant and meet Cencora Group policies and standards.

This role requires someone who is capable of leading the regulatory activities, has excellent organisation skills and attention to detail and can work on multiple projects and activities simultaneously, whilst being adaptable to changing priorities. Creating effective working relationships with internal and external stakeholders is essential.

• Responsible for managing the regulatory tasks in launching multiple NPD (New Product Development) projects as part of a multifunctional team, in accordance with the budget and 5‑year plans.
• Support the European Brand Manager and Central Sourcing Team in assessing potential new Alvita products, the launch in new territories, the evaluation of claims and product attributes of products offered by alternative suppliers.
• Review and approve Product Specifications and Artwork Management Sheets (AMS), supporting the launch of new Alvita products and update of existing products. Work…