Associate Manager, Regulatory Affairs

Exeltis & Xiromed•Florham Park, NJ

4d•Onsite

About The Position

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.

Requirements

Bachelor’s Degree (Life Science preferred)
English language proficiency
6 years of experience
Knowledge of FDA regulations and guidance
Experience with original ANDAs preferred
Experience with complex generic products, especially inhalation and/or drug-device combination products, strongly preferred.
General management skills
Strong interpersonal and people development skills
Strong results-orientation
Superior leadership skills
Ability to anticipate problems and solve them successfully
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams, SharePoint)
Proficiency in Adobe Acrobat
Proficiency in database systems
Proficiency in eCTD Compilation software

Nice To Haves

Experience with complex generic products, especially inhalation and/or drug-device combination products

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.
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.