Job Summary
A healthcare company is in need of a Remote Regulatory Affairs Manager.
Individual must be able to fulfill the following responsibilities:
- Collaborating with the R&D, Med Affairs, Clinical Affairs, Marketing and other partners
- Combining knowledge of scientific, regulatory and business issues as well as influence with health authorities
- Leading programs and/or projects in support of the regulatory demands of the business
Qualifications for this position include:
- Ability to organize and analyze technical data, identify issues or gaps and develop strategies to address any gaps is required
- Consistent record of developing and executing global regulatory strategies that align with business needs is required
- Experience with pharmaceutical requirements or combination products (e.g., drug-device or device-drug) is required
- A minimum of a Bachelor's degree with at least 8 years of relevant experience
- Foundational US and EU regulatory knowledge to maintain legal status of products and minimize risk is required
