Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a part-time **Regulatory Compliance, Controlled Substance Specialist who **will facilitate the company’s efforts to ensure compliance with U.S. and international regulations governing controlled substances, particularly as they relate to the research, development, and commercialization of novel chemical entities (NCEs).

This role involves collaborating with cross-functional teams including R&D, legal, regulatory, global product quality, manufacturing, and supply chain, to ensure the organization’s-controlled substance operations are in full compliance. The Contractor will serve as a subject matter expert on all matters related to controlled substances and develop strategies for successful compliance in a rapidly evolving regulatory landscape.

Key Responsibilities:

Compliance Leadership:

Oversee the organization’s compliance with federal, state, and international regulations related to controlled substances, including DEA (Drug Enforcement Administration) regulations.
Lead the development, implementation, and maintenance of policies, procedures, and controls to ensure compliance in all stages of the product lifecycle, from early-stage research to post-market.
Ensure adherence to DEA regulations on registration, security, recordkeeping, inventory, reporting, and disposal of controlled substances.

Regulatory Strategy for NCEs:

Develop regulatory strategies specific to novel chemical entities (NCEs) with controlled substance designations.
Collaborate with R&D and regulatory teams to assess the current or likely controlled substance status of NCEs and ensure timely submissions for required licenses and permits.
Serve as the primary point of contact for interactions with the DEA and other regulatory bodies regarding the classification and handling of NCEs.

Cross-Functional Collaboration:

Provide subject matter expertise on controlled substance compliance to internal teams including manufacturing, clinical, and supply chain functions.
Work with legal teams to interpret evolving regulatory requirements and ensure compliance with applicable laws and regulations.
Partner with R&D to develop secure protocols for the handling and transfer of controlled substances during the research and clinical trial phases.

Risk Management & Audits:

Establish and maintain a risk-based compliance monitoring program for controlled substance activities.
Serve as a subject matter expert and primary point of contact for internal audits of controlled substance activities, ensure corrective actions are implemented when necessary, and prepare the company for external regulatory inspections.
Monitor changes in regulations and industry standards, proactively adjusting compliance strategies as needed.

Training & Awareness:

Design training programs for employees involved in the handling of controlled substances, ensuring they are aware of their responsibilities under applicable laws and internal policies.
Promote awareness across the organization regarding the importance of controlled substance compliance.

Qualifications/Experience:

Education:

Bachelor's degree in Life Sciences, Law, or a related field. Advanced degree (e.g., MBA, MS, JD) preferred.

Experience:

10+ years of experience in regulatory compliance, with a focus on controlled substances in the pharmaceutical industry.
In-depth knowledge of DEA regulations and international controlled substance laws (e.g., UN Conventions, EU regulations).
Proven track record of working with novel chemical entities (NCEs) and navigating the complexities of their regulatory status.

Skills:

Strong understanding of the product lifecycle for pharmaceutical products, particularly as it pertains to controlled substances.

Term & Start

Fully Remote – some travel possible
6-month contract, with possible extension
2 Video Interviews - Start 2-3 weeks from an offer
Part-time, 40 hours/week for the first few weeks then ad hoc.

Regulatory Compliance Specialist