Senior Clinical Regulatory Affairs Manager, Buckinghamshire

Key People

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Job ID :

10815


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Buckinghamshire,Buckinghamshire,


Key Skills :

CTA, regulatory, ethics, biotech, pharma, CRO, clinical research, clinical trial applications, regs,


Salary :

£65000 - £75000 per annum + car allowance, bonus and benefits


Date Posted :

21 Mar, 2018



Company Name :

Key People


Location1 :

Buckinghamshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for a Senior Regulatory Affairs Manager / Associate Director to join a leading Pharmaceutical company based in Buckinghamshire on a permanent basis. This role has become available due to a period of growth within the company and a number of employee's receiving recent promotions.

Responsibilities:

*Leads operational activities related to clinical trial submissions to Health Authorities including Regulatory Authorities and all Independent Ethics Committees (IEC) within the EAME region. In a matrix environment you will manage team members' work on assigned clinical trial operational projects.
*Leads project management of CTA portfolio and SOP development. You will also manage the relationship with CROs and contributes to the wider European Regulatory Affairs team by providing specialist clinical trial expertise.
*Builds and maintains strong relationship with Global Drug Development
*Provides support and training for company preparation and implementation of the 2016 EU Clinical Regulation
*Develops and maintains strong working knowledge of requirements for EAME CTAs, procedures and ICH-GCP.
*Manages relationships with Regulatory and Global Drug Development/Operations staff within and outside the region to ensure effective communication and efficient implementation of clinical trial related regulatory activities.

Candidate profile / experience:

*It is essential that you have strong CTA regulatory and ethics submissions experience. Strong pharma experience is preferred.
*Proven leadership and Management skills - Due to internal promotions and re-shuffling, the team has gone through a lot of change recently so you will need to join with a strong presence!
*EU and EAME experience required. The role may expand to cover APAC in future so would be helpful to have this experience as well but not necessary
*You will be part of the Leadership Team so you will need to have strong communication skills at senior management level
*Budget management experience is required

For further details about this role, or other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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