Associate Manager Regulatory Affairs
Overview
Lead regulatory strategy for original ANDA submissions focusing on complex generic products including inhalation and drug-device combinations. Oversee submission processes and coordinate cross-functional efforts to ensure compliance and timely delivery.
What You'll Do11
- 1Support Associate Director in executing regulatory strategies for original ANDA submissions
- 2Prepare and submit regulatory dossiers variations renewals amendments and other filings
- 3Maintain updated regulatory documentation for marketed and pipeline products
- 4Monitor submission timelines and ensure deliverables are completed on schedule
- 5Coordinate document collection and organization with internal stakeholders
- 6Track regulatory commitments and respond to agency inquiries
- 7Assist in preparing technical content for complex generic products
- 8Provide regulatory input on formulation analytical manufacturing and device considerations
- 9Stay current with regulatory requirements and industry trends
- 10Participate in meetings and contribute to process improvement initiatives
- 11Ensure compliance with company policies and quality standards
Requirements11
- 1Bachelor's degree in Life Science or related field
- 26 years of experience
- 3Proficiency with FDA regulations and guidance
- 4Experience with original ANDAs especially inhalation and drug-device combination products
- 5Minimum 5 years in regulatory affairs
- 6Strong written and verbal communication skills
- 7Ability to manage multiple projects and deadlines
- 8Experience with eCTD compilation software
- 9Familiarity with Microsoft Office suite and Adobe Acrobat
- 10Travel for occasional overnight trips and local day trips
- 11Experience with database systems and technical documentation
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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