Associate, Regulatory Affairs

Independently authors, compiles, reviews, and schedules high-quality regulatory submissions in adherence with standards that are fully compliant with FDA and ICH requirements within company timelines. Submissions will include: ANDAs, NDAs, 505(b)(2), Amendments, Supplements, and Annual Reports files. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Interprets and communicates regulatory requirements and strategies, as they affect regulatory submissions, to more junior regulatory team members and to internal and external functional business units. Works on more complex projects and helps to solve problems where analysis of the situation or data requires evaluation and sound-interpretation of regulatory requirements and/or guidelines.

ORGANIZATION STRUCTURE

The Associate/Sr. Associate, Regulatory Affairs reports into the Director, Regulatory Affairs and is based in Morristown, New Jersey. Remote will be considered.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1. Oversee and manage submission compilation while maintaining adherence to FDA standards and internal requirements
2. Interact effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions, ensuring that departmental timelines are met.
3. Represent regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.
4. Independently author, compile, review high-quality, more complex, original new ANDAs, NDAs, Amendments, Supplements, Annual Reports and responses to inquiries from FDA to ensure high-quality submissions and expeditious approvals from FDA.
5. Review technical documents for accuracy and acceptability for use in new ANDAs, NDAs, 505(b)(2), Amendments, Supplements, Annual Reports and other required FDA filings.
6. Interface with project team members and functional departmental representatives to obtain documentation and establish timelines to ensure that complete and accurate submissions are prepared according to plan.
7. Review Modules in eCTD and verify proper hypertext linking.
8. Review and sign-off on change control documentation. Assess changes and their impact to the business based on an advanced understanding of regulatory guidelines and applicable federal laws.
9. Assist in formulating sound strategies in support of submission goals.

1. Participate in the development and maintenance of Regulatory systems, processes, checklists and procedures to facilitate consistency.

1. Independently track and manage all correspondence between Alvogen and government agencies, including phone calls, emails, and relevant documents.
2. Accurately update and maintain spreadsheets and databases in a timely manner.

1. Other duties as assigned.

QUALIFICATIONS

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

Job-Specific Competencies/Skills:

• Excellent verbal and written communication skills.
• Demonstrates in-depth knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output.
• Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
• Strong critical and logical thinker with ability to analyze problems and recommend solutions.
• Effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners.
• Exercises sound judgement. Demonstrates an advanced ability to make appropriate decisions on regulatory activities and work outputs.
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity.
• Working knowledge of US FDA (OGD/CDER) e-submission requirements.
• Knowledge/experience with CMC regulatory requirements.

"We are an EEO Employer, including disability & vets."