Location: Chicago area
If you are a Regulatory Affairs star, then this is the
opportunity for you. It does not matter if your background
is with small molecules, large molecules or medical
devices! If you have Regulatory Affair experience and
the drive to be a star, then you will be trained for this
brand new position working on combination biologic
and medical device products.
WHAT A GREAT WAY TO GIVE YOU WELL ROUNDED
REGULATORY EXPERIENCE WHICH MAKES YOU VERY
MARKETABLE!!
This company offers tremendous stability and they have
a vast and diverse portfolio of products. Located in the
suburbs of Chicago, you get all of the benefits of a major
metropolitan area but, by living in the suburbs, you can
realize a lower cost of living and better housing costs with
excellent schools.
WHAT THE JOB ENTAILS:
- Develop and execute regulatory plans for complex projects
including new and existing products
- Evaluate technical and scientific information, identify
deficiencies, implement and execute strategies to remediate
risks
- Ensure project teams and business objectives and
deliverables are aligned with regulatory strategy
- Represent or lead the RA function on assigned cross-
functional project teams
- Communicate proactively and report to regulatory authorities
- Maintain appropriate communication within the RA function
and other functions primarily at the project team level
- Initiate, manage and maintain operational activities in support
of new and existing marketing authorizations
- May provide direct supervision of individuals including
mentoring and performance management
- May review promotional material or SOP’s for compliance
with local and global regulations
REQUIREMENTS:
- Minimum of 4 years regulatory experience in RA or related
field, including managing people or projects
- BS degree or equivalent in related field, but relevant post
graduate degree is preferred
- Sound basis of regulatory knowledge. (biologic or medical
device or combination product knowledge is an advantage)
- Working regulatory knowledge of CMC or preclinical and
clinical product development, as well as regulatory
experience with biologics or medical device manufacturing
- Ability to manage multiple complex projects and timelines in
a matrix team environment
- Demonstrated interpersonal and collaboration skills,
including strong negotiation skills
- Strong oral and written communication and presentation
send resumes to: sue.komers@eliteresourcesolutions.com
|
