DirecciónTake your career to the next level at Labcorp as an Associate Director - Regulatory Affairs.
Labcorp's work in developing new testing solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.
Position Summary:
The Associate Director-Regulatory Affairs will provide tactical support to the Regulatory Team. They will help assemble FDA pre-submission packages, reviewing the validation plans and summaries for completeness and support internal meetings and author final product submissions. In doing this they will provide guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. This will require partnering and working across all of laboratories and the National Office of Quality.
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Other Essential Responsibilities:
- Serves as a primary internal reviewer for regulatory submissions
- Evaluate data during review of intended submission products.
- Provides science-based written and verbal feedback to the team regarding the design of their development or to review the gap analysis work to try to ensure a complete package can be assembled and submitted.
Candidates given best consideration will have the following qualifications:
- Strong collaborative, team approach.
- Scientific experience that is diverse and multidisciplinary.
- Working knowledge of protocol design and data analysis experience.
- Scientific writing and document review experience.
Education
- Required: Bachelor's degree in a relevant scientific discipline.
- Preferred: Master's, or Ph.D. degree in a scientific discipline.
Application window open through: 02/16/2024
Work Location: Remote
Pay Range: $125,000 - $190,000 annual salary + bonus potential
Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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