Title of Post: / Regulatory Affairs Project Manager
Pay Range: / D
Department/Directorate: / Regulatory Affairs
Accountable to: / Senior RA Manager (Therapeutic Area team lead)
Responsible for: / Designated regulatory projects
Liaises with: / All departments, Regulatory bodies and Authorities worldwide.
Main Job Purpose
To prepare regulatory filing strategies for new Marketing Authorisations in designated territories as well as strategies for the maintenance of existing drug licences.
To plan for and manage the timely availability of the documentation necessary for applications to relevant authorities and manage the regulatory submission process to approval, through product launch and beyond.
To write and or review scientific documents and country specific documents needed for submission for new product applications as well as during product life cycle.
To engage with regulatory bodies as required obtaining new drug licenses as well as maintaining existing licenses in order to achieve regulatory compliance.
Actively maintain information tools, documentation and procedures to ensure regulatory compliance of BPL products released to market.
Contribute to the improvement of processes and procedures within the Regulatory Affairs Department and coach other members of the Regulatory team.
Organisational Structure
Key Duties and Responsibilities
Develop business optimal product licensing strategies for designated new products and new markets.
Manage the regulatory aspects and licensing of Orphan Drugs within the designated countries.
Obtain Marketing Authorisations in the designated countries or geographical area for designated products and manage the documentation generation process, submission, assessment, approval and product launch regulatory steps.
Maintain existing licences (commitments, variations, renewals) in designated territory..
Communicate directly with the relevantBPL departmentson the generation of any regulatory documents.
Communicate directly with the MHRA (country of origin) and other health authorities seeking advice, guidance or clarification of legal issues or submission processes.Active participation in meetings with Health Authorities with or without superior.
Generate or supervise the generation of regulatory dossiers in eCTD format. This includes writing and reviewing regulatory documentation both scientific data and regional specific data.
Support commercial operations with preparations for tenders, mock-ups, samples, launches, promotional material, third party business, and distributor/agent contacts.
Actively maintain RA data bases, documentation and procedures to ensure regulatory compliance of BPL products released to market.
Acceptance and Review
Accepted
Manager Signature: ...... Print Name: ………………………Date: ......Jobholder Signature: …………………………... Print Name: ………………………Date: ......
H:\D05\DATA\PERS\Recruitment\Job Descriptions (JD)\Regulatory Affairs\2016\Regulatory Affairs Project Manager_job description_August 2016.doc