Regulatory Affairs Team Leader/ Manager

3 weeks ago

Peterborough Cambridgeshire, United Kingdom Aspire Pharma Limited Full time

Regulatory Affairs Manager - UK Team Lead
Competitive Salary & Company Benefits | Petersfield | Permanent
Monday to Friday, 9.Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world?
Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.
We are looking to recruit a friendly, determined, hard-working candidate for the role of Regulatory Affairs Manager to manage a subteam within our Regulatory Department.
Submission, maintenance and control of regulatory information and documentation for medicines, medical devices, and other products
Oversee, review and provide support for submission of new product dossiers and technical files (including own development, in-licensed and out-licensed) and all aspects of regulatory lifecycle maintenance for existing products.
Ensure all submissions to regulatory authorities are of high quality and all correspondence is conducted in a professional and timely manner.
Act as signatory for appropriate medical device technical file sections and expert reports.
Responsible for quality, maintenance, control and distribution of internal sources of regulatory information

Regulatory Strategy and Scientific Writing
Represent Regulatory Affairs as part of Research & Development (R&D) project teams and lead regulatory strategy discussions. Provide regulatory expertise to Business Development and R&D as required.
Formulate and present coherent scientific arguments and risk assessments in a written or verbal format to justify regulatory strategies and decisions made during product development and lifecycle, including at meetings with the competent authorities, in response to requests for information during regulatory procedures, or in response to product quality issues.

Lead and provide support with regulatory due diligence of new products using knowledge of current regulations and guidance.

Project management
Understand, assign and manage workload of team for assigned projects in line with business priorities. Ensure projects are driven forward in line with business priorities and timelines.

Compliance and Regulatory Intelligence
Medical Devices and related ISO activities (including ISO13485 and ISO14971); and General Data Protection Regulations and the UK Data Protection Act, as required.
Adapt regulatory or company strategy to account for changes in regulation, guidance or best practice.

Line Management
Support and manage regulatory officers in the performance of their day-to-day activities, ensuring compliance of team to company SOPs and Quality Policy/Site Master File, job descriptions, personal development plans and objectives. Effectively communicate business priorities and objectives to team.
Contribute to regulatory leadership group and foster a positive environment and high performing team.

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Minimum 5 years of UK and EU pharmaceutical regulatory experience.
Experience of line management and/or leading a regulatory team.
Good IT skills including MS Word, Excel and PowerPoint.
As well as a fantastic, inclusive company culture, where employees are truly valued and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:

~ Generous Pension Scheme.
~ Life Assurance cover and Employee Assistant Program.
~25 days’ holiday plus Bank Holidays.
~ Learning and Development opportunities.
~ Fantastic Company events and celebrations throughout the year.

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