Skip to main content

This job has expired

Senior Regulatory Affairs Director - Clinical Development

Employer
Proclinical Staffing
Location
Gothenburg, Sweden
Salary
Negotiable
Start date
21 Feb 2019
Closing date
7 Mar 2019

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

ProClinical are advertising a Senior Regulatory Affairs Director vacancy with a global pharmaceutical company with leading products across various therapeutic areas. This organisation, which focuses on pursuing world-class medicines in innovative ways, is seeking for an experienced incumbent to join them in Sweden.

Job Responsibilities:

  • Developing and implementing regulatory strategy for a product, or group of products, and ensuring that that said strategy delivers a rapid approval.
  • Identifying the needs of businesses, markets, and patients.
  • Acting as Global Regulatory Lead (GRL) for a product, or group of products.
  • Planning and constructing global dossiers and cores prescribing information.
  • Developing and implementing innovative strategies to maximise the likelihood of regulatory success.

Skills and Requirements:

  • A Bachelor's degree in a science related field and/or other appropriate knowledge/experience.
  • Previous experience in attending and/or helping a team prepare for a Major Health Authority interaction.
  • At least 5 years of experience or equivalent of regulatory drug development, including product approval/launch.
  • Expert knowledge of regulatory affairs within one or more therapeutic areas.
  • A broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g., Global, European, International, Marketing Company, or experience at a health authority.
  • Proven leadership and program management experience.
  • Ability to think strategically and critically evaluate risks to regulatory activities.
  • Ability to work strategically within a complex, business critical and high-profile development program.
  • Successful contribution to a major regulatory approval at a global or regional level.
  • A scientific and clinical understanding of the regulatory sciences.
  • Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skill.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Pontus Larsson on +44 203 319 3030 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-PL1

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert