New · posted Oct 15
Aquestive Therapeutics · Pharmaceuticals
Regulatory Affairs Strategist
- Warren, NJ
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
What you need
- 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.
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.
What you'll do
- 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.
Pay
$140,000 – $160,000 a year
Employer providedThis position has an expected base salary range of $140,000 - $160,000 annually
Where you'll work
Warren, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Warren, NJEqual opportunity, accessibility and legal noticesAquestive Therapeutics's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Senior & Principal roles in New Jersey9 roles publishing pay
Senior & Principal roles in the US53 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $140,000 | — | $160,000 |
| New Jersey (middle half) | $143,000 | $150,000 | $176,500 |
| All US (middle half) | $115,000 | $137,500 | $150,000 |
This role: Aquestive Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Aquestive Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Regulatory submissions7
- GMP and compliance5
- Documentation and SOPs3
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
Aquestive Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Quality3 75%
- Regulatory1 25%
By level
- Senior & Principal2 50%
- Director1 25%
- Associate & Specialist1 25%
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Regulatory Affairs Strategist at Aquestive Therapeutics
Open until filled. $140K–$160K a year, employer provided.