Senior Manager Regulatory Affairs - Neuroscience - Hertfordshire (Head Office)

Medical Affairs, Other

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


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Reference: 6839

We have been instructed to recruit for a dynamic and market leading Pharmaceutical company. If you are looking to work in an innovative and tenacious environment as a Senior Manager managing the Neuroscience portfolio, then this position may be for you. This exciting role will support some key early development compounds in the Neurosciences Business Group regulatory strategy team department, based at Head Office in Hertfordshire.

Essential Requirements:
Experience in regulatory methods and processes in industry setting required
Essential: experience with EU regulatory processes and environment, including clinical trials, scientific advice, PIPs and orphan drugs
Regulatory strategy experience and strong strategic thinking skills
Experience with liaising and negotiating with regulatory authorities, both verbally and in writing
Excellent written and verbal communication skills
Strong organisational and problem-solving skills
Must be able to operate in a complex environment and adapt well to change
Ability to ‘think on their feet’
Desirable; some experience in neurosciences therapy area
Educated to a high degree level

Role Responsibilities:
This position is to support some key early development compounds in our client’s Neurosciences Business Group regulatory strategy team. The appointed person will be the EU Regulatory Lead for early phase epilepsy and/or Alzheimer’s Disease compounds.
Input to global regulatory strategy, including design of clinical development programmes, will be an important part of the role.
Upcoming submission work will include leading the preparation of orphan drug applications, PIPs and clinical trial applications, seeing these applications through to approval and maintaining the approval as required.
Close working with the US based Global Regulatory Lead and the Project Team will be required.
Involvement in post-approval work for Centralised products may also be part of the role.
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
Present 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

Role Specific Competencies:
Learning on the fly
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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