Regulatory Affairs Associate
Roles and Responsibilities:
- The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance.
- The Senior Specialist is also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.
- Work independently and effectively with other functions to manage and prepare regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations.
- Assess post approval changes, provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies.
- Ensures important submissions/tasks are completed on a timely basis .
- Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones.
- Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.
- Continuously build and share knowledge of CMC related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards.
- Identify and communicate potential regulatory issues to management, as needed.
- Performs other tasks as requested by management.
Education and Experience:
- Minimum 4 years' experience in Regulatory Affairs publishing and reviewing the documents in a pharmaceutical environment, with strong familiarity with regulatory eCTD submission process.
- Must be highly proficient in Microsoft office, Adobe Acrobat, ISI writer and ISI Toolbox (with proven background in bookmarking and Hyperlink, page stamp, masking, and watermarks etc.,).
- Experience in Safety Submissions and publishing Clinical Study Reports. OPDP - Submitting Promotional Material for marketed products Office of Prescription Drug Promotional material (OPDP), which is also called as Division of Drug Marketing, Advertising, and Communications (DDMAC) Submission.
- Also experience in publishing documents Like IMPD, PSUR, DSUR using TRS Publisher.
- Knowledge of eCTD submission eCTD Validator, eCTD Viewer and Life Cycle Management
- Must experience in Document Management Systems (example, Livelink, Documentum)
- Knowledge in scanning document.
- Knowledge in FDA & ICH Guidance's
- Must be able to do multi-task and work well under tight timeliness.
- Strong verbal and written communication skills