Associate/Sr. Associate Regulatory Operations, CMC

This position is primarily responsible to plan, coordinate and prepare regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements. Serve as a primary publisher of US Regulatory submissions and system administrator for Alvogen's US Regulatory electronic submission management system. This position will also plan, coordinate and write CMC submissions such as annual reports, amendments, and supplements in compliance with FDA requirements and within company timelines.

ORGANIZATION STRUCTURE

The Senior Associate, Regulatory Operations/CMC reports into the Manager/Director, Regulatory Affairs or equivalent and is based in Morristown, New Jersey.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1. Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time.
2. Works with the Manager and document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements.
3. Maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.
4. Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
5. Assists in monitoring and maintaining familiarity with evolving and/or new regulatory e-submission requirements and under the direction of the Manager of Regulatory Operations, ensuring that all functional disciplines are apprised of the changes and trained accordingly.

1. Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Submission Management System.
2. Independently tracks and manages all correspondence between Alvogen and government agencies, including phone calls, emails, and relevant documents.
3. Accurately updates and maintains trackers, spreadsheets and databases in a timely manner.

1. Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
2. Monitors and maintains the highest level of submission standards.
3. Trains new employees in Alvogen submission processes and procedures.
4. Reviews technical documents for accuracy and acceptability for use in ANDAs, NDAs, Amendments, Supplements, Annual Reports and other required FDA filings to ensure high-quality submissions.
5. Independently authors, compiles, reviews and submit high-quality, Amendments, Supplements and Annual Reports.
6. Performs other related duties as assigned.

• Minimum of a Bachelor's Degree in a life science. Advanced degree preferred.
• Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs.

Job-Specific Competencies/Skills:

• Proficient in Microsoft Word, Excel, PowerPoint. Access database proficiency a plus.
• Knowledge of eCTD publishing systems (ie. Lorenz Docubridge), EDMS technology and related publishing tools.
• Working knowledge of US FDA (OGD/CDER) e-submission requirements.
• Knowledge/experience with CMC regulatory requirements.
• Excellent verbal and written communication skills.
• Highly motivated, results driven individual with unyielding predisposition to detail, accuracy and clarity.
• Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
• Must be able to work independently and possess excellent decision- making and problem-solving skills.
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Strong critical and logical thinker with ability to analyze problems and recommend solutions.
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.

We are an EEO Employer, including disability & vets.