- Demonstrated success in the management of regulatory submissions such as as CE Mark for Class II-III products, IDE’s, IND’s, 510(k)’s, NDA’s, ANDA’s
- Knowledge of technical aspects of regulatory profession, combined with scientific understanding and project management skills
- Understands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges and ability to resolve them through collaboration
- Recognized as an emerging authority within the business or function with broad understanding of and experience working with multiple functions that are unrelated
- Able to manage ambiguity and have ability to fill gaps with alternative data
- Expert with Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures
- Possess business insight and have ability to understand how product approval strategy interacts with business strategy, may involve in creating/ proposing such strategy
- Nimble learning and able to actively seek out relevant legislation and competitive information on product lines
- Must be results oriented and decisive. Failure to obtain results or arrive at appropriate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.
- Demonstrated analytical and creative thinking skills and the ability to solve complex problems
- Able to mentor and develop talent of direct reports
- Ability to interact with diplomacy and tact while maintaining appropriate assertiveness
- Willingness to take ownership and accept responsibility, ensuring accountability for actions and decisions
- Must be detail oriented, well organized and able to work both independently and in teams
- Knowledge and use of relevant PC software applications and skills to use them effectively
- Demonstrated ability to communicate effectively both verbally and in writing
Certificates, Licenses, Registrations
Regulatory Affairs Certification (RAC) desired.
An equivalent competency level acquired through a variation of these qualifications may be considered.
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Some travel may be required (5-10%)