Mosaic Regulatory Solutions
Location
Devon | United Kingdom
Job description
Senior Regulatory Specialist - 10 years experience - of CMC , regulatory strategy, project management , scientific advice
Location - East Midlands / Remote working with 2/3 days in the office
Salary - On application
Purpose of Job • Undertake regulatory activities as assigned by Regulatory Manager/Associate Director of Regulatory • Direct line management of members of regulatory team as required • Provide regulatory support for development activities • Provide regulatory support for other departments • Involvement in regulatory team activities as required to improve processes and procedures • Input and participate in Business Development activities, as required • To actively manage clients.
Qualifications and Role Requirements • Minimum of 10 years direct Regulatory Affairs experience • Scientific academic qualification or extensive relevant experience in the pharmaceutical sector • Subject matter expertise of relevant guidance in EU and GB for medicines • Computer literate across a number of applications, including Microsoft Office • Ability to solve complex problems and to manage issues constructively. • Self-motivated individual with ability to take ownership and organize allocated project work on day-to-day basis with limited guidance, and to delegate routine tasks to junior colleagues where appropriate. • Ability to communicate effectively, both oral and written format to support actions, decisions or justifications for complex issues. • Subject matter expert in multiple competency areas of regulatory affairs Relevant Regulation and related issues • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended • Human Medicines Regulations 2012 and Statutory Instruments. • Data Protection legislation.
Holdings SOPs and allied documents.
Responsibility to: Regulatory Manager/Team Leader Direct relationships: Head of Regulatory Associate Director Regulatory Senior Management team QPPV & QP (UK & EU) Other staff External development partners and clients External consultants and contractors Regulatory Authorities
Direct reports: Regulatory Team members as appropriate Indirect relationships
Main Duties and Responsibilities • Preparation and submission of Marketing Authorisation applications and other regulatory submissions to EU regulatory authorities • Marketing Authorisations lifecycle maintenance of EU and overseas licences including preparation of variation and renewal applications as appropriate • Maintenance of high quality internal records and documentation linked to all areas of the business • Nominated regulatory project manager or consulted subject matter expert. • Regulatory lead on regulatory strategy, scientific advice and regulatory due diligence projects. • Assessing and determining prioritisation of projects: • Providing regulatory support and advice to other areas of the business. • Training and mentoring new regulatory staff members • Liaison with suppliers, clients, development partners and regulatory bodies • Ensure guidelines and legislation knowledge is current • To have good awareness of future developments in the regulatory arena by CPD • Ensure knowledge of SOPs is current & recorded, according to training matrix relevant to the role • To assist management in development of departmental systems and procedures • Assisting in growth of the regulatory consultancy business – business development proposals, external meetings, presentations, networking and training as required • To partake when needed in client meetings and meetings with competent authorities
Job tags
Salary
