PSG Members,
The
WEBSITE: howardclark@
COMPANY NAME: Howard Clark Associates
ADDITIONAL INFO:
Regulatory Affairs- Lead Scientist(s)
We havebeen selected to work on (2) dynamic full time Lead Regulatory Affairs Scientists opportunities. 1 in Inflammation and the other in Homeostasis’. These outstanding opportunities are for a global leading Pharmaceutical company. Our client is a leading organization that is experiencing unprecedented growth! The successful candidate will assist senior Regulatory Affairs personnel in assuring compliance. You will submit all types of applications to the FDA as well as provide significant input into the development of the regulatory strategy documents for development of regulatory submission strategies.
Skill Set
- Regulatory
Skill Level
- Permanent
Compensation
Up to $140K Base
Requirements
Essential functions of this position include the following:
- In this role you will report to the designated Director or Senior Director, Therapeutic Area.
- You will Work with other personnel in the Medical Department and counterparts in Regulatory Affairs.
- Your External relationships include interaction with FDA personnel regarding project issues.
- You will Promote and develop initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives.
- You will act as an advisor to subordinates and may supervise or manage junior or more experienced personnel. You May also lead FDA meetings.
Experience
Experience Required:
- The essential functions of this position include but are not limited to:
- 1) SUBMISSIONS: Submit all types of applications to FDA. Provide significant input into development of comprehensive regulatory strategy documents. Facilitate and organize the compilation of applications (
IND - 2)FDA COMPLIANCE: Provide training to the Sales Reps as needed. Provide information and training in areas of
IND - 3)FDA INTERACTIONS: May act as FDA liaison for most project issues. Lead FDA meetings. Lead label negotiations. Participate in and/or coordinate all negotiations and interactions with FDA personnel on projects as assigned.
- 4)PRODUCT DEVELOPMENT AND SUPPORT: Manage moderately complex to complex projects. May act as GRT member. Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products and for 510(k) devices under development or license for assigned projects. Supervise all regulatory activities relating to regulatory compliance for assigned marketed and investigational products. Supervise and advise staff members.
- DEVELOPMENT OF PEOPLE: Manage assigned junior to more experienced personnel as direct report. Ensure that the IDP development forms are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of policies, procedures. Contribute to development of Therapeutic Area Associates and Managers.
- Bachelors/Life Science degree required. Advanced degree preferred.
- Minimum 6 years regulatory experience required; 10 years total industry/FDA experience.
- Regulatory project management experience required; supervisory management experience preferred.
- Experience and knowledge of the current requirements of FDA.
Email your resume to howardclark@
LOCATION:
As always, please keep us informed of any successes that you have.
Good Luck!
Paul S. Grant
____________
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Professional Services Group
Ph: 973-361-1034
Fx: 973-361-8727
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