Expiry Date: 28-05-2021
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
**Regulatory Affairs Snr Manager**Work on Biological development projects and lead MAA's** Great Training Available**
Company Location Brussels, Brussels Capital Region, Belgium (Full and extensive re-location package available).
This is a great opportunity to be part of something special… and this is the perfect role for a regulatory professional with experience of development projects or supporting MAA’s and/or lifecycle activities to take a central role with a high level of strategic input for EU development projects and CeP submissions for Biological indications in both mid and late stage development (with great training available).
In the short term you will operate as the strategic regulatory liaison for your projects, and in the longer term you will continue to grow and development experience across a strong portfolio where you will move up to become a Global Regulatory Leader or potentially manage a team.
Within this dynamic global regulatory affairs environment you will be working in a mixed role covering drug development, product registrations & line extensions of biotech products/projects where you will also receive great training and the opportunity to cross into new therapy areas and cover all stages of development.
As the Regulatory Affairs Snr Manager you will lead the cross-functional submission teams to ensure creation and submission of qualitative regulatory documents within defined timelines as per company objectives including response to questions; acting as the regulatory lead for all CTA, PiP and ODD applications conducted in the European region; ensuring appropriate contacts with relevant regulatory agencies, especially the European Medicines Agency and regulatory agencies in the EU member states to facilitate approval in a timely manner.
This organisation excels as a company because of its continual high standards in training and development of all research staff. Their integrity, knowledge and creativity drives them forward, helping this Global Pharma company to stay innovative in a highly competitive market.
The salary, benefits and relocation package for this organisation are excellent and you will also receive real training and career progression for an organisation that is well known for giving its regulatory leaders strong career development. We offer you an exciting job and challenges in an international company, career development opportunities, a good work/life balance and an attractive salary package with extra-legal advantages.
Qualifications & Experience needed:
- Degree in Life Sciences (Pharmacy, Biology, Chemistry...)
- A minimum of 5 years Regulatory Affairs experience
- Good communication and organization skills
- Excellent knowledge of English (written and spoken).
To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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