Our client are looking for a dossier compliance manager to join their team. They are the world's most international tobacco group, operating in more countries than any other,
This role will have senior responsibility for the dossier compliance content of the CBD product portfolio which is relied upon by BAT compliance and product/project delivery teams. The role is responsible for managing and directing all regulatory development/needs in terms of dossier management, linked to assigned CBD products in order to complete dossier preparation on time and secure registrations.
- Formulate, lead and deliver dossier compliance, as part of the technical compliance evaluation package which is relied upon by BAT compliance and project delivery teams.
- Prepare a regulatory technical dossier for each assigned CBD product, which covers the main points outlined in the project overview.
- Be the primary contact point on Dossier Management for CBD products.
- Participation in regulatory processes to gain and maintain GB and European authorisations for CBD products (application, renewal, variations) via sound technical dossier management.
- Prepare a summary of work plans and priorities for each assigned CBD product technical dossier together with Critical Success Factors (CSFs). Communicate these plans to the Product Compliance, associated R&D and legal (LEX) teams and to marketing and sales colleagues (as required).
- Deliver on the agreed technical dossier registration plan - to be delivered on time and to specification and within budget.
- Be pro-active, take initiative, be critical, show diligence and patience, be precise (good compromise between quality and time needed to write the dossier), work in a more or less autonomous way, in a well-structured, well organised manner to write clear technical dossiers with sound argumentations.
- Write, review and update training materials, guidance documents, SOPs and work instructions on dossier processes.
- University education Master's degree level - Scientific/Technical Management, Pharmaceutical, Chemistry, Clinical discipline(s).
- Regulatory affairs certification (or equivalent).
- Proven ability to meet critical dossier submission deadlines and manage multiple business-critical projects.
- Proven track record of dealing with regulatory authorities.
- Expert knowledge of dossier management and the regulatory requirements.
If this role sounds like something you would be interested in, please send your CV, ideally in Word format, via this site.
If this role is not quite right for you but you would like to have a conversation about other roles, please search and connect with me, Nikita Sheth, on LinkedIn.
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