Regulatory Affairs Strategist

Aquestive Therapeutics, Inc.; New Jersey; Hybrid; USD 140,000 - 160,000; Full time

Job summary

Aquestive Therapeutics, Inc. in Warren, NJ seeks a Regulatory Affairs Strategist to develop and execute regulatory strategies that support product approvals and lifecycle management.

The role requires FDA knowledge, coordination with R&D, Quality, CMC and Commercial teams, preparation of INDs/NDAs/CTAs, and interaction with health authorities worldwide. The candidate should have an advanced degree, RAC is a plus, 5+ years in regulatory affairs, and strong communication and project management

Qualifications

• Advanced degree in Life Sciences or Regulatory Affairs.
• 5+ years regulatory affairs experience in pharma/biotech.
• Strong knowledge of FDA requirements and global regulations.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Develop and implement regulatory strategies across product pipelines.
• Draft and submit INDs, NDAs, CTAs to FDA and international agencies.
• Interpret and apply FDA/ICH regulations and monitor changes.
• Provide regulatory guidance to cross-functional teams.
• Maintain submission tracking systems and filings.
• Interface with senior management for project updates.

Skills

Regulatory affairs

FDA regulations

Project management

Cross-functional collaboration

Communication

Education

Advanced degree in Life Sciences/Regulatory Affairs

Tools

eTMF

Regulatory databases

Submission platforms

Job description

Aquestive Therapeutics, Inc. | Corporate Office
30 Technology Dr
Warren, NJ 07059, USA

Description

Job Summary

The Regulatory Affairs Strategist is responsible for developing and executing regulatory strategies that support the approval and lifecycle management of pharmaceutical products. This role serves as a key liaison between the company and regulatory agencies, ensuring compliance with applicable regulations while facilitating timely submissions for clinical trials, marketing authorizations, and post-approval changes.

Working cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, the strategist provides regulatory guidance throughout all phases of product development. The ideal candidate will possess strong working knowledge of FDA regulations (including IND and NDA processes), international regulatory environments, and experience preparing regulatory documentation.

This position requires strategic thinking, attention to detail, and the ability to navigate complex regulatory frameworks to support innovation and business goals.

Job Responsibilities

• Develop & implement regulatory strategies across product pipelines, including NDAs, BLAs, and supplements.
• Draft and submit regulatory documents (e.g. INDs, NDAs, CTAs) to the FDA and international agencies (Canada, Europe, UK).
• Interpret and apply regulations (FDA, ICH, cGMP, USP standards) and monitor changes that may affect product development.
• Provide regulatory guidance to cross-functional teams—R&D, clinical, CMC, quality, and commercial.
• Maintain submission tracking systems, regulatory databases, and filings.
• Interact with regulatory agencies, managing agency correspondence, meetings, and scientific advice requests.
• Identify and mitigate regulatory risks, ensuring compliance and protecting timeline integrity.
• Support global strategies, including alignment with non U.S. jurisdictions where applicable.
• Lead and manage responses to Health Authority information requests.
• Work with CROs, consultants, and the internal team as required to plan, manage, and support regulatory deliverables related to US and EX-US submissions for assigned projects.
• Interface with senior management to provide project updates.
• Anticipate regulatory risks and propose mitigation strategies.
• Coordinate and prioritize assigned projects according to company goals.

Qualifications

• Advanced degree in a scientific discipline required (Life Sciences, PharmD, Regulatory Affairs, or related).
• RAC certification is a strong plus.
• 5+ years of regulatory affairs experience—pharma, biotech, or medical devices.
• Deep knowledge of FDA requirements and global regulations.
• Track record in preparing and submitting regulatory filings.
• Proficient in project management, communication, and negotiation.
• Experience with submission platforms, eTMF, and regulatory databases.
• Excels at cross-functional collaboration and facilitates effective communication and alignment across diverse teams.
• Excellent oral and written communication skills.
• Experience developing and implementing successful regulatory strategies.
• The candidate should be detail oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This position has an expected base salary range of $140,000 - $160,000 annually

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.