|
| |
Associate Director, Regulatory Affairs
| Base
Salary : |
$135,000.00+ based on
qualifications |
| Job
Location : |
Ridgefield Park, NJ |
|
Candidate Citizenship / Residency Requirement : |
US Citizen or Permanent Resident [Green
Card Holder] |
| New
Position : |
Yes |
|
Employment Type : |
Full Time
|
| No. of
Openings : |
1 |
|
Experience Required : |
5 - 10 years
|
| Degree
Required : |
Graduate Degree
|
| Job
Description : |
Develop, implement and execute regulatory strategic
plans and best practice departmental procedures for the therapeutic area
group.
Provide regulatory guidance for top-level project development/core
teams.
Actively liaise with FDA and regulatory authorities to provide/solicit
guidance and support for complex submissions.
Research and develop regulatory intelligence concerning competitor
products and disseminate competitive intelligence to project and core
teams.
Staff training/management and self-development.
Pharmaceutical industry experience required
Bachelor’s degree in scientific discipline required (Life Sciences,
Chemistry, Toxicology or Pharmacology). Doctorate degree highly desired
(e.g., MD, JD, Pharm D, or PhD in life sciences).
3-8 years FDA experience as Project Manager or Clinical Reviewer.
Expert understanding of pharmaceutical operations and regulatory
compliance requirements together with broad understanding and experience
of the clinical development process a plus.
Expertise in managing relationships and interfacing with regulatory
bodies as an articulate communicator with strong negotiation skills a
plus.
|
|
Candidate Must Have : |
-
Pharmaceutical
industry experience required
-
Doctorate degree
highly desired (e.g., MD, JD, Pharm D, or PhD in life sciences).
-
3-8 years FDA
experience as Project Manager or Clinical Reviewer.
|
| We Will
Sponsor/Transfer H-1B and/or H-2B Candidates : |
No |
| Other
Details : |
Industry : Bio-Tech , Healthcare , Hospital , Medical , Pharmaceutical
Department : Clinical Research Organization , Healthcare , Regulatory
Affairs/ Medical Affairs
Relocation : YES
Specific Relocation Details :
Will discuss during interview
Qualified candidates
please forward professional resumes along with a cover letter outlining
salary history, geographic preferences and availability in complete
confidence to:
Frank Sinclaire
- Health Care Division Group
Manager
fsinclaire@pailingroup.com
Pailin Group Professional Search Consultants
Retained Executive Search Consultants Nationwide
info@pailingroup.com
Contact A
Consultant
Back To
Assignments
|
|
