Canopy Life Sciences is a well-respected vendor & partner in the life sciences industry, assisting pharmaceutical and life sciences clients in various functional areas of expertise. Our culture is one of empowerment. Everyone has a voice and plays a role in the success of the business and a role in developing our values & behaviors. We recruit, train, and develop people to ensure the very best for our client partners.
Position Overview:
We are looking for a Senior Manager, Regulatory Affairs, Operations to oversee regulatory submission processes and document management. The ideal candidate will have a strong understanding of regulatory requirements and experience managing submissions to global health authorities. This role requires expertise in regulatory operations, including electronic submissions, publishing, and compliance with industry regulations.
Key Responsibilities:
Manage the formatting, submission, and archiving of regulatory documents.
Coordinate with external vendors for eCTD submissions and electronic filings.
Act as the regulatory representative for submission sign-off and ensure compliance with regulatory reporting timelines.
Develop and maintain regulatory submission timelines and internal tracking systems.
Provide guidance on submission strategies and coordinate internal and external resources.
Lead process improvements within regulatory operations.
Communicate evolving regulatory publishing and reporting requirements to stakeholders.
Oversee technology, systems, and tools related to submission planning and document archiving.
Assist in developing and implementing SOPs, Work Instructions, and training materials for regulatory activities.
Maintain document templates and internal style guides to ensure compliance with regulatory requirements.
Ensure adherence to company policies and regulatory standards.
May require occasional international travel.
Perform other duties as assigned.
Qualifications:
Bachelor's degree in a scientific discipline with 8+ years of regulatory operations experience in pharmaceuticals, biotechnology, or contract research organizations.
At least 5 years of experience in a management role within a pharmaceutical or biotech environment.
Strong knowledge of regulatory submission processes, including eCTD and global health authority requirements.
Familiarity with FDA/EMA regulations and ICH guidelines.
Expertise in document management, publishing software, and submission planning.
Advanced proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat.
Strong problem-solving skills, attention to detail, and the ability to manage multiple projects.
Excellent communication and collaboration skills to work effectively across teams.
This is a hybrid position based in Boston, MA, with a requirement of at least two days per week in the office. Exceptional candidates from other locations may be considered.