Regulatory Operations Specialist
2 weeks ago
We are seeking a highly skilled Regulatory Operations Contractor to join our team at Beacon Hill Life Sciences in Boston. This is a contract position through the end of the year with possible extension.
About the JobThe successful candidate will assist in the development and implementation of systems and procedures used to support regulatory submission activities, including eCTD production, document publishing, and document management.
This role requires strong technical skills, excellent communication and interpersonal abilities, and experience compiling electronic submissions and in electronic document publishing.
Responsibilities- Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities;
- Coordinate and participate in the production of electronic regulatory submissions;
- Support and conduct cross-functional training on submission standards, procedures, and systems as required;
- Support compliance with worldwide submission regulations and guidelines.
- Experience compiling electronic submissions and in electronic document publishing;
- Experience compiling IND, NDA/BLA, and CTD submissions;
- Understanding of eCTD submission requirements;
- Excellent communication and interpersonal skills;
- Demonstrated ability to work well with cross-functional teams;
- Demonstrated ability to manage priorities and work under tight deadlines;
- 2+ years of pharmaceutical industry experience preferred;
- Proficient with Microsoft Office products and Adobe Acrobat.
- A competitive salary of $$80,000 - $110,000 per year, depending on experience;
- A dynamic and supportive work environment;
- Ongoing training and professional development opportunities;
- A comprehensive benefits package.
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Boston, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeAbout the JobBeacon Hill Life Sciences - Boston seeks a highly skilled Regulatory Operations Contractor to support regulatory submission activities, including eCTD production, document publishing, and document management.Job SummaryThis role involves assisting in the development and implementation of systems and procedures used to support regulatory...
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