Job Summary
The Regulatory Affairs Associate I assists in the preparation and submission of regulatory documentation to ensure compliance with global standards.
This role involves supporting regulatory strategies, preparing reports, and coordinating regulatory submissions.
The associate will also help manage licensing activities, support CARES Act reporting, and contribute to various regulatory projects.
Key Responsibilities Assist in preparing responses to global information requests and regulatory maintenance documents (amendments, supplements, annual reports, safety reports, etc.)
within defined timeframes.
Contribute to determining regulatory strategies for manufacturing changes and regulatory activities.
Help in the preparation of Lifecycle Management reports, such as Annual Reports and Drug Master Files (DMF).
Coordinate and track workflows for regulatory submissions to ensure timely and accurate completion.
Ensure all regulatory submissions comply with global regulatory standards.
Participate in project team meetings and interact with sub-teams to support regulatory objectives.
Assist with and eventually lead licensing activities and required updates (Establishment Registration, State Licenses, etc.).
Support reporting requirements under the CARES Act.
Provide additional support to Regulatory management as needed.
Required Qualifications Bachelor's degree in a scientific field (preferably Chemistry or Pharmacy) with 1-3 years of related experience.
OR Master's degree in Regulatory Affairs with at least 3 months of regulatory experience (internship).
Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Project).
Experience with Document Management Systems and online resources.
Knowledge of global regulations and current Good Manufacturing Practices (cGMP).
Preferred Qualifications Experience with regulatory submissions for international markets.
Prior involvement in lifecycle management or pharmaceutical licensing activities.
Familiarity with regulatory reporting requirements under the CARES Act.
Skills & Competencies Strong PC literacy and ability to use technology tools efficiently.
Familiarity with global regulatory requirements and cGMP standards.
Ability to work independently with appropriate supervision.
Excellent organizational, interpersonal, and communication skills (both oral and written).
Education: Bachelors Degree, Masters Degree