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Job Details

Senior Project Manager Regulatory Affairs

Company: Docs Global (Continental Europe)
Location: Naarden,Netherlands
Reference: Ref AS-019665
Closing Date: 06 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

For the right candidate there will be a profitable package offered in an expanding and international company based in the Netherlands.

Requirements:

Roles & Responsibilities of the position

Leads the process of preparing, assessing and submitting regulatory documentation to relevant regulatory authorities (local or EMA) for assigned product(s) in order to support and facilitate the process of approval.
o Leads the preparation, writing, review and submission of regulatory documentation and submissions
o Leads the organization of meetings with authorities regarding these submissions
o Discusses submissions with relevant authorities EMA
o May act as primary contact point for communications with the regulatory authorities relating to a particular matter
o Leads the execution of operational activities relating to the submission process
o Responsible for ensuring that regulatory documents are archived and systems are updated for assigned product(s)
o Reviews new information and data related to assigned product(s)
o Advises and contributes to the planning and development of the global RA strategy for assigned product(s)
o Leads the development and implementation of the regional RA strategy for assigned product(s) and its alignment with the global RA strategy
o Reviews development plans for the assigned product(s) from a regional regulatory perspective
o Scientifically assesses all relevant documentation related to assigned product(s) for their compliance with regional, national or other regulatory requirements

Job Requirements

o Master’s degree+ Life Sciences
o At least 7 years of relevant work experience in Regulatory Affairs, at a regional and/or global level
o Analytical with a problem solving approach
o Good planning, project, process, and people management abilities
o Strong communication and negotiation skills
o Excellent scientific writing skills
o Good networking capabilities
o Able to lead and organize others without having direct authority
o Able to multi-task and perform well under pressure
o Strong understanding of organizational and inter-cultural sensitivities and able to apply this knowledge to day-to-day practices
o Fluent in spoken and written English

Remuneration & other details

To get more information, please call; Jakob Schönberger at +31 6 42427987 or send your CV to jakob.schonberger@docsglobal.com

Apply for this job: Senior Project Manager Regulatory Affairs

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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