Senior Manager, Regulatory Operations
Company: System One
Posted on: February 20, 2021
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
- 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
- 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
- Demonstrated record of business integrity, and making sound
regulatory compliance decisions when assessing and mitigating
- Experience in vendor management of outsourced regulatory
- 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.
Keywords: System One, Cambridge , Senior Manager, Regulatory Operations, Executive , Cambridge, Massachusetts
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