Our client are a multinational FMCG business who are looking for a Global Regulatory Affairs Manager to join their team based in East Yorkshire. Extensive Regulatory Affairs experience and experience in health care product development is required.
Responsibilities:
Develop and implement regulatory strategies that enable the delivery of pipeline of products to meet the Category Strategies for Hygiene; this includes global positioning of products as medicinal and medical devices depending on country of launch
Ensure the delivery and maintenance of master Medicinal dossier (eCTD) for Hygiene Products
Ensure application of and support for new registrations, renewals, variations and regulatory authority feedback
Ensure a quality audit for all Medicinal and medical device dossiers is conducted
Ensure notification of class I, II medical devices to the appropriate Competent Authority
Monitor, collect and interpret regulatory issues and trends that potentially will impact products, policies and procedures, share this information with appropriate local and global functions and provide regulatory leadership for the development of strategies and action plans to address them
Interface with relevant government authorities (where needed) and ensure enquiries received from regulatory authorities in reference to submissions are addressed by working closely with relevant functioning groups. This includes MRP/DCP submissions in EU as well as Class I-II medical devices
Advise Global Category Development, Regional Scientific Services and Business on regulatory requirements and regulatory impact during early phases of the NPD process for medicinal and medical device positioned projects intended for launch
Work collaboratively with appropriate company personnel and contractors (when required) to define global regulatory dossiers for the medicinal and medical device positioned projects
Requirements:
Educated to honors degree level in Chemistry, Biological Science Pharmacy or Toxicology
Experience with Health Care Product development and extensive experience in Regulatory Affairs
Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders
Prior experience in US OTC and medical devices (Class I-III) is preferred
Solid experience in medicinal EU requirements and CTD structure is preferred
Prior experience in dealing with EU Medicinal Agency (EMEA) and/or MHRA is desirable
Proven ability to work under pressure without compromising on deliverables
Experience with recruitment, management and development of people
To apply for this position, candidates must be eligible to live and work in the UK
Matchtech is acting as an Employment Business in relation to this vacancy.