Senior RA Associate

Job title : Senior RA Associate
Location : Zürich (Kreis 3)
Job type : Permanent
Salary : Negotiable
Contact name : John Spring
Contact email : john.spring@secpharma.com
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 john.spring@secpharma.com or call +44 (0) 207 255 6600