Regulatory Specialist I conducting regulatory activities for health care facilities across Florida. Prepares reports, manages files and provides support for QA reviews in the agency.
About the role
- Director of Regulatory Affairs leading regulatory process improvements for vaccines. Collaborating with teams across the US to ensure compliance and strategy alignment.
Responsibilities
- Lead regulatory process improvements and support regulatory activities across the United States
- Work closely with cross-functional teams, external partners, and senior leaders to simplify processes, reduce cycle times, and improve quality
- Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans
- Lead interactions with local / regional regulatory authorities
- Ensure the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
Requirements
- Bachelor’s degree in Biological or Healthcare Science
- Extensive Experience (5+ years) in regulatory affairs across all phases of drug development
- Proven track record in leading regional development, submission, and approval activities
- Experience working on clinical trial and licensing requirements in major countries
- Experience in Vaccines Regulatory Affairs
Benefits
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
- Annual bonus
- Eligibility to participate in share based long term incentive program
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