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Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: England, England
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: 73475-PHARM-DEB_1550574537
Contact Name: Denise Saab
Contact Email: Denise.Saab@volt.eu.com
Job Published: February 19, 2019 11:08

Job Description

Our client is a scientifically-driven, global, full-service clinical contract research organisation (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
We are seeking a full-time Regulatory Affairs Manager who will work on a team to accomplish tasks and projects that are instrumental to the company's success.
The company offer a fantastic package
Pension - 3% by employee, matched by employer up to 6% - 8%
25 days holiday + bank holidays and the days over Christmas.
Life Assurance x4 times base salary
Private medical insurance
Season ticket loan
Eye test contribution of up to £25, with a contribution to glasses of up to £50.
Free onsite gym between 7am - 8pm inc swimming pool.
Responsibilities
*Project management focus to facilitate full global regulatory submissions
*Providing regulatory advice and guidance to other company department to ensure compliance with EMA regulations and requirements
*Interaction with EMA and other regulatory agencies;
*Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the EMA
Qualifications
*Bachelor's degree and significant (at least 5 years' experience) regulatory affairs experience
*CMC experience preferred

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