Job Title: Senior Manager Regulatory Operations
Location: Cambridge, MA
Type: Full Time, Salaried with Benefits
Start Date: Immediate
Global Pharmaceutical Company is looking to add a Senior Manger of Regulatory Operations to their team!
- Ensures the creation of high-quality regulatory submission packages that meet company requirements along with regulatory agency electronic submission requirements and guidelines, ensuring timely delivery to health agencies
- Serves as primary interface between internal staff and external vendors, coordinates regulatory meetings and oversees the scheduling and coordinated completion of publishing deliverables.
- Responsible for development of submission plans, with content timelines and workflow tracking.
- Ensures organization and maintenance of Health Authority correspondence and regulatory information files.
- Contributes to the evaluation, testing and implementation of regulatory tools, technology for dossier management, publishing, archiving and submission.
- Monitors the development of new regulatory requirements or guidances and advises on the impact to the business.
- Identifies potential risks, developing mitigation plans for resolution of risk factors, along with status and escalation planning.
- Contributes to development and implementation of regulatory standards and procedures for dossier management, publishing, archiving and submission processes.
- Advises Clinical Development on products that are in-development, collaborating cross-functionally on preparation and submission of regulatory filings.
- May be required to perform other duties, as assigned.
- BS degree is required, preferably in the life sciences
- A minimum of six to eight years of regulatory experience in the pharmaceutical industry, which includes four to six years of managing multiple projects in regulatory operations.
- Knowledge of drug development and the necessary support operations, and the associated regulatory requirements.
- Success in regulatory planning, dossier generation, publishing, and submission of all US dossiers; NDA/BLA experience is highly desirable.
- Demonstrated record of business integrity, and making sound regulatory compliance decisions when assessing and mitigating risks.
- Experience in vendor management of outsourced regulatory operations work.
- Demonstrated success streamlining document preparation across all internal functions as well as with external vendors, with a focus on opportunities for process improvement.
- Understanding of US regulations and guidelines pertaining to electronic records and signatures and eCTD standards.
- Possesses a solid foundation of regulatory knowledge and drug development experience, so as to be able to access, apply and interpret regulatory information.
- Knowledge of and ability to interpret scientific data, as it relates to regulatory requirements.
- Strong organizational and time-management skills, with ability to work to timelines and meet project milestones.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
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