**Regulatory Affairs EU Project Manager **Work on Bio dev. projects and lead MAA's** Great Training Available**

On Application
15 Nov 2018
02 Feb 2019
* TMADV / 191018A

**Regulatory Affairs EU Project Manager  **Work on Bio dev. projects and lead MAA's** Great Training Available** 

Location: Brussels, Belgium

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 EU Project 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 3 years  Regulatory Affairs experince

- Good communication and organization skills

- Excellent knowledge of English (written and spoken)

Please note if this role isn’t for you but you know someone who might like this role, please make a referral and receive a great bonus (new laptop, flights to Paris or Rome or a new ipad) if your referral leads to a placement.


If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.

About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

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