Job Title: Regulatory Project Manager
Date Posted: 09-18-2007
Job Location: New Jersey-Central
Job Type: Contract
Education Level: Bachelors Degree
Work Experience: 5+ to 7 Years
Job Shift: First Shift
Yearly Salary:DOE (Depend on Experience)
Company Name: ParmaLink Consulting
Contact Information: Tracy   Bowden (tbowden@pharmalinkconsulting.co.uk)
Job Description:
Regulatory Project Manager - New Jersey, USA

 

Pharmalink Consulting are thrilled to announce the opening of a new role within our US
office.

 

This role, reporting to the Director, Regulatory Operations, will be focused on establishing
and leading a skilled project team, within the pharmaceutical regulatory compliance sector.

 

We are seeking a hands on project manager, experienced in full life cycle delivery, centered
on regulatory strategy and client liaison.

 

Duties

 

Global Regulatory Project Management

 

Deliver key objectives as part of a regulatory compliance project. 
Ensuring that project work proceeds according to agreed client deadlines. 
Providing regulatory consultation for in-house and remote regulatory projects. 
Assisting in client development activities, as required - travel to client sites nationally
and internationally may be involved. 
Establishing and developing key contacts with regulatory authorities and clients, nationally
and globally.
 

Team Management

 

Leading and management of a team of permanent regulatory consultants, providing guidance and
expertise as required. 
Supervision and development of regulatory consultants - junior to senior executive level.
Their project duties include review of regulatory dossiers to ensure compliance  with product
licences, submitting post approval applications, and collecting submission data and regulatory
intelligence.
 

Qualifications required

 

Life sciences degree preferably in Chemistry or Pharmacy. 
Post graduate qualification in a relevant subject and/or post-graduate courses in Regulatory
Affairs would be an advantage. 
At least 5 years broad based progressive regulatory experience within the pharmaceutical
industry.
 

Key skills required

 

Strong regulatory project management experience with the persistence and drive to meet
deadlines. 
Proven ability to manage and lead teams. 
Mentoring experience. 
Possession of first rate written and verbal communication skills. 
A dynamic and active disposition with good teamwork skills. 
Strong influencing ability and business acumen. 
Demonstrate good working knowlege of IT systems.
 

Benefits

 

This opportunity is available in a freelance capactiy or there is the opportunity to join our
rapidly expanding team of regulatory consultants on a permanent basis.

 

The permanent position offers a competitive benefits and training package dependant upon
skills and experience. We will also consider relocation.

 

 

Pharmalink Consulting is striving to develop the best regulatory professionals of the future,
so you must be an enthusiastic individual, ready to face the challenges of joining a dynamic,
forward thinking company at an important time of expansion and development.

 

 


 
 

Additional Information

 
Competitive benefits and training package dependant upon skills and experience. 
Position Type: Full Time, Temporary / Contract / Project, Permanent 
Ref Code: TB090805USARPM
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