Senior Manager Regulatory Affairs - Growth Markets - Hertfordshire (Head Office)

Medical Affairs, Other

East Anglia, East Midlands, London, South East (Excluding London)


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Reference: 6838

We are currently recruiting for a market leading Pharmaceutical organisation with an exciting new opportunity working as a Senior Manager within the Growth markets. This exciting role will be working across the Regulatory Affairs department, based at Head Office in Hertfordshire.

Essential Requirements:
Experience in regulatory methods and processes in industry setting is required
Experience in working with emerging markets within EMEA
Has experience developing regulatory strategies for NDA's/MAA's/significant line extensions/ CMC lifecycle management
Has experience working across multi-functional teams including Commercial, and external partner management.
Has cultural awareness and experience of working with people from different cultural backgrounds.
Is able to undertake long distance travel, some of which may necessitate travel at weekends
Educated to a high degree level

Role Responsibilities:
To apply a broad knowledge and interpretation of regulatory requirements in Growth Markets and our client’s products to the drug development process, including promulgation of health authority marketing authorization dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives. Ensure that regulatory documentation meets relevant regulatory requirements and our client’s quality standards.
Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
Work may include policy changes or recommendations
Individual contributor with specialised knowledge
Has an easily discernible impact on the job area and expected results
Typically, no cost center budget management responsibility
Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures
Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
Called upon to develop solutions utilising creativity and ingenuity
Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organisation as a prime contact for technical matters of significant complexity
Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees
Work is completed under limited supervision
Typically reports to an Associate Director or above

Role Specific Competencies:
Timely Decision Making
Priority Setting
Presentation Skills
Developing Direct Reports and Others

Recruitment Process:
2 stage process

Highly competitive package + bonus/bens

Evolve Selection is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions.

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