Job Description

Job Description

Job Description

Role Overview 

The Associate Manager, Regulatory Affairs supports the planning, preparation, submission, and maintenance of regulatory filings to ensure compliance with applicable health authority requirements. This role works closely with cross-functional teams, including Quality, R&D, Manufacturing, Pharmacovigilance, Medical Affairs, Supply Chain, and other technical functions to support product development and lifecycle management, with a focus on original ANDA submissions for complex generic products, including inhalation and/or drug-device combination products. The Assistant Manager helps ensure that regulatory strategies are executed effectively and that documentation is accurate, complete, and submitted within required timelines. This role is best suited for a candidate with a strong interest in technically challenging products and regulatory strategy for complex generics.

Primary Duties & Responsibilities

• Support the Associate Director of Regulatory Affairs in executing regulatory strategies for original ANDA submissions, with emphasis on complex drug dosage forms, including inhalation and/or drug-device combination products.
• Prepare, compile, review, and submit regulatory dossiers, variations, renewals, amendments, and other regulatory filings in accordance with applicable regional and global requirements.
• Maintain and update regulatory documentation for marketed products and pipeline products.
• Monitor submission timelines and ensure regulatory deliverables are completed on schedule.
• Coordinate with internal cross-functional stakeholders to collect, review, and organize required documents and data for submissions.
• Track regulatory commitments, agency correspondence, and approval timelines.
• Assist in responding to health authority questions, deficiency letters, and requests for additional information, particularly for technical and CMC-related topics.
• Support the preparation and review of technical regulatory content for complex generic products including inhalation and/or combination products.
• Provide regulatory input on development activities involving formulation, analytical, manufacturing, and device-related considerations, as applicable.
• Stay informed on current regulatory requirements, guidance documents, and industry trends relevant to complex generics, inhalation products, and combination products.
• Participate in internal meetings and provide regulatory input to support project planning and decision-making.
• Contribute to process improvement initiatives within the Regulatory Affairs function.
• Ensure all activities are conducted in compliance with company policies, quality standards, and applicable regulatory requirements.

Additional Duties & Responsibilities

• Process documents, prepare, assemble, compile and publish regulatory submissions in Electronic Common Technical Documents format (eCTD) as required.
• Support the review and organization of submission components to ensure technical accuracy, completeness, and consistency across dossiers.

Competencies/Career level

Innovation, entrepreneurial attitude, customer orientation, team leadership, adaptability/flexibility, results-oriented, control of budgets/costs, Self-development.

Requirements and personal skills

• Education: Bachelor’s Degree (Life Science preferred)
• Languages: English
• Experience (years/area): 6
• Specific Knowledge: FDA regulations, and guidance; experience with original ANDAs preferred; experience with complex generic products, especially inhalation and/or drug-device combination products, strongly preferred.
• Travel: Minimal
• Personal skills: General management skills, strong interpersonal and people development skills, strong results-orientation, superior leadership skills, ability to anticipate problems and solve them successfully.
• Proficiencies: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams, SharePoint); Adobe Acrobat; database systems; eCTD Compilation software

Physical Demands

This job operates in a professional environment. This role routinely uses standard office equipment such as computers, phones, printers, etc. 

Travel: Some overnight travel may be needed for this position. There may be occasional local day travel.

Position Type and Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m. 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  The employee:

• Is required to interact with internal and external contacts independently
• Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
• Is often required to stand, walk, bend, lift, or sit.
• Is required to occasionally lift office products and supplies, up to 40 lbs.
• Is desk-based and may be sitting for long periods of time.
• Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
• Must communicate clearly: phone calls, emails, in-person conversations
• Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.

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