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Job Details

Director, Regulatory Strategy

Company: INC Research
Location: UK Regional, Europe
Reference: 16005006
Closing Date: 16 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development.

Requirements:

We are currently looking to strengthen our Regulatory Consulting team in Europe and are seeking a Director, Regulatory Strategy to join our Global Consulting group.

A brief summary of duties you will be involved in as a Director, Regulatory Strategy:
• Responsible for the management and development of the regulatory management team and staff

• Interact with senior management and staff on operational procedures and processes within the Regulatory department to ensure compliance

• Direct and oversees all regulatory aspects of clinical product development including, but not limited to, preparing and reviewing regulatory submissions (such as INDs, NDAs, IMPDs, CTD, eCTDs), reviewing clinical site regulatory documents, assisting executive management with the administration of the Regulatory Affairs Department, developing work flow, and regulatory records document processes

• Participate and lead business development initiatives

Qualifications
 

To succeed in this role you will need the following skills/experience:
• Degree in the science/health care field or equivalent combined education and experience, MD or PhD preferred
• Extensive clinical research experience and significant supervisory and/or project management experience
• Demonstrated expertise in at least one area of clinical product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development

• Experience or familiarity with document preparation and/or publishing systems preferred

• Knowledge of procedures for reporting non-clinical and/or clinical study data

• Extensive knowledge of FDA regulations and medical terminology


Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”

What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

 

Apply for this job: Director, Regulatory Strategy

Contact Information:

Address:  INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
1126
Hungary
Tel:  +36 1 489 48 56
Website:  Visit Our Web Site

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