Senior Manager, Regulatory Affairs
Azurity Pharmaceuticals, Inc.
Full time- 8+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Apr 26, 2024
- End Date: Jun 26, 2024
- 8+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Apr 26, 2024
- End Date: Jun 26, 2024
Skills:
- pharma
- MS Office
- Regulatory Affairs
Job Description:
Responsibilities
- Represent Regulatory Affairs and is responsible for articulating regulatory strategy including regulatory advocacy for development and post approval change activities.
- Serve as primary interface with FDA and other regulatory agencies.
- Review all the technical submission documents and provide regulatory feedback to ensure completeness, accuracy, and regulatory compliance.
- Manage regulatory filings (IND, PIND, Pre-NDA, Pre-ANDA, CGT, PFC, iPSP, Controlled Correspondences, NDA, ANDA, ODD etc.), including authoring scientific briefing book packages, eCTD sections in accordance with regulatory guidelines, applicable federal laws, and statutory requirements.
- Manage operational aspects of preparing compliant submissions to regulatory agencies.
- Establish and manage timelines associated with regulatory submissions in alignment with business priorities.
- Manage and address deficiencies (IR, DRL and CRL) received from FDA within pre-defined timelines, with adequacy and accuracy in consultation with stakeholders.
- Responsible for managing and tracking regulatory-related changes.
- Responsible for evaluating post approval change controls as per the regulatory agency guidelines to determine the appropriate reporting category and explicitly defining the necessary conditions and documents needed to implement the change.
- Manage archival of regulatory submissions, contact reports and correspondence logs.
- Provide regulatory guidance on requirements for development projects, as required.
- Keep abreast of current regulations and regulatory guidance, assessing impact to assigned projects and internal processes.
- Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
- Develop collaborative and respectful relationships with internal and external partners, ensuring activities are performed according to regulatory strategies and assisting with regulatory questions.
Qualification & Experience
- Master of Pharmacy (M. Pharm): Minimum of 12 years of pharmaceutical industry experience; minimum of 8 years of regulatory experience; clinical experience preferred.
- Excellent organizational, interpersonal, verbal, and?written communication skills, strong grammar, and?proofreading/editing skills, and MS Office skills are required.
- Track record of successfully working with cross-functional teams, including external partners
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Salary
Not Disclosed
-
Role
Manager
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Area of Practice
- Regulatory Affairs
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Experience
8+ years
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