Regulatory Affairs - Umanist Staffing LLC

Overview:

The Regulatory Affairs role is crucial within the organization as it ensures compliance with all regulations and laws governing the industry. This position plays a key role in obtaining and maintaining market access for products, ensuring that all regulatory requirements are met, and providing strategic regulatory guidance to internal teams and stakeholders.

Key Responsibilities:

Develop and implement regulatory strategies for product approvals and compliance.

Review and approve labeling, advertising, and promotional materials.

Assess and communicate regulatory risks and impact on product development.

Monitor and interpret regulatory intelligence to ensure ongoing compliance.

Prepare and submit regulatory submissions, including INDs, NDAs, and annual reports.

Coordinate and support regulatory agency inspections and audits.

Advise cross-functional teams on regulatory requirements and changes.

Manage regulatory document control and archiving processes.

Conduct regulatory impact assessments for product changes or new product introductions.

Provide regulatory training and guidance to internal stakeholders.

Participate in internal and external audits to ensure compliance with regulations.

Contribute to the development and improvement of regulatory processes and systems.

Collaborate with external consultants and regulatory agencies as needed.

Stay updated on global regulatory requirements and industry best practices.

Required Qualifications:

Bachelor's degree in a relevant field such as Pharmacy, Life Sciences, or a related discipline.

3+ years of experience in regulatory affairs within the pharmaceutical, medical device, or biotechnology industry.

Demonstrated knowledge of FDA, EMA, and other global regulatory requirements.

Experience with regulatory submissions and interactions with health authorities.

Strong understanding of GMP, GCP, and GLP regulations.

Excellent project management and organizational skills.

Ability to analyze complex regulatory issues and provide innovative solutions.

Proficient in interpreting and applying regulations to product development initiatives.

Effective communication and negotiation skills with regulators and internal stakeholders.

Experience in preparing and reviewing regulatory documentation and reports.

Attention to detail and ability to prioritize tasks in a fast-paced environment.

Proven track record of successful regulatory approvals and compliance activities.

Ability to work independently and as part of a collaborative team.

Proficiency in regulatory software and document management systems.

Certification in Regulatory Affairs (RAC) is a plus.