Job Details  
Advertiser: Haybury

 
Job Title: Global Regulatory Affairs Manager –
Location:Germany
Rate:£ Per Year    Benefits: Excellent
Description: A great opportunity has arisen to work within one of the world’s leading Pharmaceutical companies who are headquartered in Germany. With an impressive product portfolio and strong pipeline they are looking for an experienced Global regulatory affairs manager to lead a number of new submissions in both Europe and the USA.


Within this role you will:

• Lead and coordinate all regulatory strategy for early development and late stage projects for assigned therapeutic area
• Prepare technical documents appropriate for regulatory submissions
• Responsible for providing regulatory advice to support product maintenance
• Coordinate and conduct interaction with the health authorities
• Review key regulatory documents such as clinical trial reports, protocol, PIP applications and CTA/IND’S

You will bring to the role:

• Degree in life science, pharmaceutics, natural science or medicine (such as MSc, PhD, MD)
• Minimum 5 – 8 years’ Experience within the pharmaceutical industry
• Experience within Biologics
• Proven experience within a regulatory affairs setting for both development and established products
• Registration experience within Europe as a minimum, USA exposure would be beneficial but not a prerequisite
• Therapeutically exposure in Immunology

In return you will receive:


• An excellent salary package including relocation support
• The opportunity to work in a global and state of the art environment
• Career growth opportunities


Key Words: Regulatory, director, Regulatory Affairs, development, strategy, Global, US, European, FDA, MAA, EMA, Strategy, Cross Functional, LCM, lifecycle manager, submission, applications, dermatology, skin, psoriasis, therapeutic, EU, IND, NDA,


If you have the skills and experience for this opportunity and the ambition to take on this position, please call Briony for further details or email your CV today.

Contact Briony at +44 1273 727 930 / 06994 329 282 or briony.tutt@hayburysearch.com

Briony is a Search Consultant at Haybury Pharmaceutical Search covering Europe, UK, North America and Asia.


Skills Required: Regulatory, director, Regulatory Affairs, development, strategy, Global, US, European, FDA, MAA, EMA
Job Type: Permanent
Start Date: ASAP     Duration:
Contact: Briony Tutt Contact E-mail: Click
Contact Tel: 01273 727 930 Contact Fax: 01273 327 685
Reference: BT5764 Added: 16-08-2017
  IMPORTANT: For jobs based in the UK it is unlawful to employ a person who does not have permission to live and work in the UK. Please ensure you have this permission before applying, unless the advert states otherwise.
 
 
 
 
 
 
 
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