Senior RA Associate

SEC Recruitment
Closing date
1 Oct 2020

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Regulatory Affairs
Full Time
Contract Type
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Senior Associate - Regulatory Affairs

A great opportunity to work with a fast-growing and pioneering biopharma organisation, specialising in multiple therapy areas including rare diseases has arisen and is a fantastic position for an aspiring RA professional with experience in the biotech industry. This role offers an excellent career growth pathway and a chance to work internationally, within some of the most exciting fields of medicine.

Salary & Benefits:

Dependent on location - details on request

Role and responsibilities:

- Preparation and submission of MAAs, variations and annual update reports for EU, and assistance for US and APAC regions
- Management of the pricing & reimbursement applications in the DACH region (Germany, Austria and Switzerland)
- Submissions of CTAs for clinical programs in Europe, and active involvement for US and APAC regions
- Preparation of modules for the e-CTD dossier
- Act as the key company contact for health authority and head organisations
- Management of national regulatory commitments and submissions
- Management of orphan drug designations for EU, US and also Switzerland
- General regulatory advice to the company's management team

Requires skills and qualifications:

*Advanced degree in a scientific or related discipline
*Working knowledge of international regulatory standards in the areas of quality, safety and efficacy
*Experience with the EU centralised procedure
*Ability to create and maintain relationships with internal/external customers

To apply for this position and put yourself under immediate consideration, send your CV to or call +44 (0) 207 255 6600

It’s easy to say, ‘we’re different’ as a recruitment business, which is why at SEC we like to show our candidates and clients that we are through our actions and our delivery. We are a life sciences and IT specialist recruitment agency that lives by four core values of trust, honesty, integrity and commitment. To us these are more than just words on a website. These are ways in which we want you to feel every time you talk to us.

Our aim is to be the European life sciences partner of first choice to everybody who works with us. We speak over 20 different languages collectively and can support you with what you need.

So, talk to us. Call us, browse our jobs, see how we are helping change both people and employers’ lives.

Contact Us
  • 3rd Floor,
  • 13-15 Moorgate
  • EC2R 6AD
  • GB
  • 00 44 (0) 207 255 6600
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