Associate/Sr. Associate, Regulatory Affairs
This role’s primary responsibility is to assist Regulatory therapy area leadership in preparing, submitting, and maintaining regulatory filings and registrations for domestic and international regions. This Regulatory Associate will coordinate, track and eventually forecast activities with internal Regulatory Affairs team members and, as directed with external parties (e.g., vendors, consultants, etc.) to maintain up-to-date information in the regulatory files and support regulatory obligations and compliance.
- Work within the Regulatory Affairs function on document preparation, information management, file maintenance, and coordination of tasks across multiple departments. Maintain submission planning and interact with publishing vendor.
- Maintain data in information systems or databases to ensure complete records, and, create and/or maintain tracking/log and/or auditing activities. This includes maintaining regulatory submission records from publisher to support Rosetta, and other file maintenance systems (as directed).
- Provide technical/quality review of data or reports to be used in regulatory submissions for new products or changes to existing health authorities’ filings, including domestic and international submissions and registration.
- Ensure compliance with regulations. Create and maintain system for notifying individuals and teams on new, applicable guidances.
- Manage and support routine US and ex-US submissions for new and ongoing clinical studies.
- Manage and support administrative obligations and file management for new and ongoing studies, as applicable, with external (eg, Legal Representative, etc,) and internal (eg, Legal, Corporate Compliance, etc) groups.
- Evaluate applicable laws and regulations to determine impact on company activities.
- As directed, partners with various teams throughout organization (Clinical Operations, R&D, Quality, Commercial etc.) on projects.
Preferred Education and Experience
- Bachelors or advanced degree in a scientific discipline.
- Minimum of 2-3 years of industry experience related pharmaceutical development, with minimum 1 year of regulatory experience a plus.
Preferred Skills, Qualifications, or Technical Proficiencies
- Understanding of product development, including research, clinical trials, manufacturing, regulations, and approval processes.
- Good written and verbal communication skills, including the ability to interact effectively.
- Good attention to detail.
- Ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations.
- High functioning as both a team player and individual contributor.
Learn more here
Job posted: 2021-03-20