The Senior Manager, Regulatory provides regulatory guidance and critical review of documents for global submissions to regulatory authorities while ensuring that submissions are in-line with the regulations. This position also supports the maintenance and regulatory compliance activities throughout the company. Assignments may include: serving as the regulatory representative on project teams, managing the review and coordination of the quality submissions to support the filings and communicating changes of laws, regulations and standards. Additionally, this individual will act as the primary point of contact and be responsible for the management of any vendors which support the regulatory submission process. In addition to assigned projects, responsibilities include the ongoing evaluation of processes and systems relative to industry best practices, resource management and ensuring compliance with evolving U.S. and international regulations and guidelines.
- Project Support: Assist in overseeing project submission planning and managing timelines, schedules and regulatory submission processes.
- Collaborate with the functional leads to prioritize and align deliverables
- Provide regulatory support to the assigned teams (review clinical protocols, informed consent forms, Investigator’s Brochures, CMC and site documentation)
- Provides regulatory operations expertise and leadership to the cross functional teams in a representative function supporting both premarket authorizations and post approval activities.
- Regulatory Submissions: Oversees and prepares documentation to support regulatory filings to ensure accuracy, applicability, consistency and control of regulatory documents. Interacts with SMEs for accuracy of content.
- Assists with the development of technical documents for regulatory filing.
- Assist the Regulatory Lead in meetings for Response to Heath Authority requests, content verification and follow-ups with functional leads.
- Manage workflows for documents
- Coordinate and prepare responses to Requests for Information from health authorities
- Operations/Systems: Provide regulatory eCTD publishing and submission support to INDs, CTAs, IMPDs. NDAs, JNDA/BLAs and other regulatory submissions
- Identify, implement and administrate enterprise document management systems and publishing tools such as: file transfer, tracking and archival.
- Advise and train on acceptable eCTD and document publishing formats to ensure compliance globally across industry standards
- Perform quality assurance of submission documents and published output to ensure compliance with global eCTD requirements.
- Assist with development and implementation of processes related to submission standards, working practices and quality controls.
- Surveillance/Intelligence: Monitors changes in regulations and keeps project teams and management informed of such changes as well as maintains familiarity with current and future global regulatory submission standards.
- Other duties as assigned.
- Bachelor’s degree in a scientific discipline. Advanced degree is preferred
- At least 7 years pharmaceutical industry experience
- Minimum of 5 years Regulatory Affairs and/or Regulatory Operations experience
- Knowledge and experience of eCTD publishing and submissions is required
- Knowledge and experience with enterprise document management systems (eDMS), preferably Veeva RIM
- Knowledge of U.S. and international regulations including cGMP, GCP, GLP, ICH guidance documents
- Knowledge and understanding of global industry standards, guidelines and validation concepts, including eCTD format and registration tracking
- Ability to manage multiple projects, with the ability to adapt to changing priorities and negotiating solutions
- Ability to work with high level contacts and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment
- Professional, proactive demeanor and strong interpersonal skills
- Excellent written and verbal communication skills
- Excellent organizational skills
Job Location: Cambridge, MA
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