- 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.
- Authorship and/or review of technical documentation, including EU eCTD dossier sections, technical file documents and product artwork, for alignment with applicable regulations and guidance and assessing suitability for submission where appropriate.
- 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.
- Due diligence
- 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.
- Artwork and labelling
- Maintain oversight and responsibility for the artwork process and staff
- Act as final signatory on print proofs
- Compliance and Regulatory Intelligence
- Maintain awareness of existing and new legislation/guidance relating to EU, UK and RoW (as required) GxP; Medicines; Medical Devices and related ISO activities (including ISO13485 and ISO14971); Controlled Drugs; Nutritional Products; In Vitro Diagnostic Devices; Biocidal Products; and General Data Protection Regulations and the UK Data Protection Act, as required.
- Understand and communicate impacts of updates to the relevant stakeholders and drive required changes in procedure. 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.
- Educated to degree or equivalent level within life sciences or chemistry.
- 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.
- Highly organised, with strong attention to detail.
- Strong problem-solving skills and ability to work independently.
- Strong communication skills, written and verbal.
- Generous Pension Scheme.
- Life Assurance cover and Employee Assistant Program.
- 25 days' holiday plus Bank Holidays.
- Learning and Development opportunities.
- Excellent opportunities for progression.
- Fantastic Company events and celebrations throughout the year.
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Regulatory Affairs Manager - Petersfield, United Kingdom - Aspire Pharma Limited
Description
Regulatory Affairs Manager - UK Team LeadCompetitive Salary & Company Benefits | Petersfield | Permanent
Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day)
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.
Do you want to be part of the journey?
If so, here is your chance
The Role
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.
What will you be doing?
The Person
Why join us?
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:
