Regulatory Affairs Manager

• 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 collaboratively with other colleagues responsible for originating artwork and provide final approval of artwork for allocated projects
• Assess the regulatory requirements for products ensuring the product and its labelling are legally compliant
• 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 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
• Ensure that Regulatory Intelligence data is maintained and updated according to the relevant processes. Demonstrate an innovative approach to obtaining market intelligence from suppliers and/or other sources, which can support the brand and local commercial teams in identifying new product opportunities and developing long-term NPD plans
• Support the business on regulatory impacting changes, to ensure the necessary steps are taken to mitigate risk to the business
• Manage the preparation and submission of the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) Marketing Authorisation Applications (MAAs), involving more than one market
• Co-ordinate the management of variations with suppliers and local regulatory teams for European Procedures involving more than one market, ensuring all MAs and products in market 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 market
• Manage the regulatory information within Samarind RMS for European procedures, involving more than one market
• Contribute as a “key” member of the team responsible for the successful implementation of Identification of Medicinal Products (IDMP) standards into the IT tools and business processes in accordance with legislative deadlines
• Review and approve promotional materials and content on platforms to ensure compliance with relevant legislation and requirements
• Support in collaboration with the European Head of Regulatory Affairs and Pharmacovigilance and the local regulatory teams the development of appropriate global and local SOP’s and working practices, to optimise the effective handling of regulatory tasks related to Alliance Healthcare product portfolio or the development of new processes necessary to deliver compliance with European and local legislation
• Provide training as author and or subject matter expert where applicable
• Work collaboratively and build strong working relationships with central and local cross-functional teams to manage the assessment of new products and maintenance of existing products in the Alvita and Almus ranges
• Take a vital role in the Monthly Operational NPD Meetings with the European Business units

• Degree in life science of science
• Experience working within European Regulatory Affairs team, supporting pharmaceutical products and or medical devices or cosmetics
• Competent in managing European Procedures (MRP/DCP’s)
• Good communicator, both orally and in written form
• Good interpersonal skills. Proven ability to operate within a multifunctional team
• Analytical, diligent and accurate
• Excellent organisational skills and ability to prioritise
• Can do attitude, with strong accountability and ownership
• Comfortable with a fast pace and switching between competing priorities
• Fluent English
• Good knowledge of Microsoft Office
• Self-motivated dynamic individual, with the ability and desire to work proactively, with limited supervision
• Ability to prioritise and organize workload and react to the changing needs of the business
• Have a proven track record of working effectively under pressure
• Ability to interpret legislation and evaluate impact on the business
• Appreciation of the commercial goals of the organisation and the desire to contribute to the successful fulfilment of these goals
• Proven ability to communicate clearly and logically, both orally and in written form
• Knowledge of appropriate European regulations and guidelines within the Medicinal Products, Medical Devices and Cosmetics Industry
• Experienced in submitting new MAA’s for European procedures
• Experience of medical devices legislation and working on medical device products
• Good working knowledge of pharmaceutical legislation

Additional language skill in addition to fluent English, although not mandatory