Abbreviated New Drug Application, Business Development, Change Control, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Detail Oriented, Document Management, Drug Development, Due Diligence, Editing, FDA (Food and Drug Administration), FDA Requirements, Healthcare, International Health, Interpersonal Skills, Investigational New Drug (IND), Leadership, Marketing, Medical Affairs, Microsoft Office, Negotiation Skills, New Drug Application, Organizational Skills, Presentation/Verbal Skills, Process Improvement, Product Lifecycle, Product Marketing, Proofreading, Quality Assurance, Regulations, Regulatory Requirements, Regulatory Submissions, Set Goals, Technical Operations, Time Management, Writing Skills
Brief team/department description:
As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies. The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.
Principle Responsibilities:
- Provide regulatory assistance with due diligence requests to support new business development activities.
- Support interaction with FDA and other regulatory agencies for assigned commercial products.
- Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.
- Manage the timelines associated with regulatory submissions such as post-marketing periodic reports.
- Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.
- Provide regulatory guidance on requirements for post-approval changes, as required, for assigned products.
- Review and provide regulatory assessments for change control documentation.
- Provide regulatory support to regulatory leadership meetings and presentations.
- Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes.
- Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
- Other duties as assigned.
Qualifications and Education Requirements:
Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.
Combination of education and applicable job experience may be considered.
Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
Ability to work independently with minimal supervision in a fast-paced deadline driven environment.
Keen attention to detail.
Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met.
Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.
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Azurity Pharmaceuticals Inc