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Job Details

Regulatory Affairs Manager

Company: Regulatory Professionals
Location: Galashiels
Reference: JO-1812-421016
Closing Date: 06 Mar 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

An opportunity has arisen for a Regulatory Affairs manager to come and join the team at an R&D based life sciences company that has a global footprint within biotechnology.

Requirements:

Regulatory Affairs Manager - Permanent
Scotland, UK
Reference number: JO-1812-421016

Extremely Competitive salary and benefits package
An opportunity has arisen for a Regulatory Affairs manager to come and join the team at an R&D based life sciences company that has a global footprint within biotechnology. This company have an incredibly exciting portfolio that has astonished and inspired all people that cross paths with their work. Their mission is to continue to be innovative and continue to transform lives dramatically with the constant passion and excitement of the company.


Coming from a strong Regulatory background, you will be expected to:

-Manage the compliance to relevant regulatory legislation and guidelines.
-Define the project and product regulatory strategy of the Development Group in line with commercial and company strategy, consulting with appropriate departments within the business where necessary.
-Represent the regulatory affairs department at project team meetings for defined projects, providing information, feedback and strategic advice..
-Manage the preparation, attendance and follow-up of meetings with appropriate Regulatory Agencies (e.g. requests for scientific advice) including the generation of briefing documents and minutes.
-Manage the production of all regulatory submissions including applications for clinical trials and marketing authorisations.
-Ensure full maintenance of clinical trial authorisations including follow-up of commitments as a condition of approval.
-Provide support for regulatory activities associated with due diligence for in- and out-licensing activities.
-Manage the provision of information requested by regulatory authorities.
-Ensure efficacious communications between the Development Group and regulatory authorities, licensing partners and country contacts.
-Have an involvement in the selection of junior regulatory staff, development and training.


As a successful applicant, you must have:
-A Life science qualification with a minimum of extensive experience in regulatory affairs in the pharmaceutical industry.
-Expert regulatory knowledge
-The ability to manage staff

If this role is of interest to you, and you would like to have a confidential more in depth chat regarding the position then please give me a call on 01189522797.
Alternatively, feel free to email me your CV to natasha@regulatoryprofessionals.com for immediate consideration.

If this role is not quite right, no worries at all. If youre interested in hearing about other great career opportunities, then please still get in touch as there are numerous Regulatory requirements at the moment. Additionally, if you know someone that may be interested in this role then we reward 250 worth of vouchers for every successful placement so please let me know!

Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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