Regulatory Affairs Director/ Manager

REGULATORY AFFAIRS DIRECTOR / MANAGER

Location: Dallas, Texas (On-Site)

Status: Full-Time

Start Date: Immediate

COMPANY INFORMATION

AP Manufacturing Solutions, LLC is a leader in next-generation manufacturing and compliance services, built on a foundation of integrity, innovation, and accountability. Our mission is to design, produce, and deliver premium quality products that meet and exceed the highest standards of safety, consistency, and regulatory compliance in industries such as FDA-regulated manufacturing and emerging nicotine alternatives.

We believe in fostering an environment grounded in respect, continuous learning, and professional growth. Our team plays a meaningful role in the company’s success, with opportunities to directly influence our operational, scientific, and regulatory excellence. At AP Manufacturing Solutions, you will become part of a fast-growing organization with a commitment to regulatory rigor, product safety, and long-term sustainability.

JOB SUMMARY

The Regulatory Affairs Director / Manager will be responsible for shaping and executing regulatory strategy across AP Manufacturing Solutions. This role serves as the primary interface with federal and state agencies including the FDA, EPA, and TCEQ, and ensures the successful registration, documentation, and ongoing compliance of all facilities and products.

This individual will oversee the development of compliant regulatory frameworks, lead the preparation of PMTA submissions, and work closely with internal departments to guide product and facility compliance. The Regulatory Affairs Director / Manager will also play a critical role in training internal stakeholders, managing regulatory audits, and developing long-term compliance strategies consistent with evolving industry regulations.

RESPONSIBILITIES

· Lead all regulatory and compliance activities, including FDA PMTA submissions, product listings, establishment registration, and post-market reporting.

· Develop, implement, and oversee regulatory management systems that align with 21 CFR Parts 111, 117, 210–211, and other federal regulations and guidance.

· Act as the company’s primary representative during regulatory inspections, audits, and formal communications with agencies.

· Collaborate with Quality Assurance, Production, Engineering, and Scientific teams to ensure regulatory compliance is integrated throughout the manufacturing lifecycle.

· Maintain current knowledge of changing regulatory requirements to assess potential business impact and guide risk mitigation strategies.

· Oversee preparation of standardized documentation, including SOPs, corrective action plans, deviation reports, product listings, and audit findings.

· Evaluate regulatory risks and develop strategies for preventing or mitigating non-compliance or legal exposure.

· Mentor cross-functional teams on regulatory compliance, best practices, and professional standards.

· Collaborate with external consultants, legal advisors, and third-party laboratories to support regulatory submissions and audits.

MINIMUM EDUCATION, EXPERIENCE & SKILLS

· Bachelor’s degree in Regulatory Affairs, Life Science, Engineering, or related field preferred.

· 7–10 years of experience in regulatory roles within FDA-regulated industries (nicotine, pharmaceutical, medical device, or dietary supplement experience strongly preferred).

· Demonstrated experience preparing and managing PMTA or similar regulatory submissions.

· Thorough knowledge of FDA regulations, product lifecycle requirements, and Good Manufacturing Practices (GMP).

· Excellent written and verbal communication skills with a proven ability to develop compliance narratives and audit responses.

· Ability to build and lead cross-departmental regulatory initiatives and foster a compliance culture within fast-paced environments.

PREFERRED QUALIFICATIONS

· Advanced degree or professional certification in Regulatory Affairs (RAC) preferred.

· Experience in ENDS (electronic nicotine delivery systems), e-liquid manufacturing, or aerosol-based product categories or other FDA-regulated industries (pharmaceutical, food, cosmetics, nicotine, or similar).

· Experience leading regulatory projects in early-stage or growing organizations.

COMPENSATION

$100,000 – $180,000 annually, based on experience and qualifications.

Incentive Structure

This position will include a performance-based incentive program to reward the achievement of key regulatory, compliance, and operational milestones. The specific structure and performance metrics will be finalized as the company transitions into full-scale operations.

BENEFITS

A comprehensive benefits program will be established and finalized once the company is fully operational. The intent is to provide a competitive package that includes health coverage, paid time off, retirement plan options, and other employee benefits aligned with industry standards and long-term growth.

Job Type: Full-time

Pay: $100,000.00 - $180,000.00 per year

Benefits:

• Health insurance
• Paid time off
• Retirement plan

Work Location: In person

Salary : $100,000 - $180,000