Regulatory Affairs Specialist

Job Description

Location: Durham, NC

We are seeking a knowledgeable and detail-oriented Regulatory Affairs Specialist to join a leading organization in the life sciences sector. Based in Durham, NC, this role is pivotal in ensuring that regulatory strategies and submissions align with applicable regulations and support the development and approval of products. The ideal candidate will have experience in regulatory documentation, submission processes, and cross-functional collaboration to ensure compliance across the board.

Responsibilities:

• Prepare, review, and submit regulatory documents to the FDA and other global health authorities in support of product approvals, renewals, and updates.
• Maintain up-to-date knowledge of applicable regulations and proactively assess the impact of changes on company operations.
• Coordinate with cross-functional teams (e.g., Clinical, Quality, R&D) to gather and compile information needed for regulatory submissions.
• Assist in the development and execution of regulatory strategies for new and existing products.
• Monitor submission timelines and ensure regulatory deliverables meet company and agency deadlines.
• Track and manage regulatory correspondence and responses to agency inquiries in a timely and accurate manner.
• Maintain regulatory files and ensure documentation is audit-ready and aligned with internal SOPs and industry standards.
• Participate in regulatory inspections, audits, and project team meetings as needed.
• Communicate regulatory requirements and updates effectively to internal stakeholders.

Qualifications:

• Bachelor’s degree in life sciences, regulatory affairs, or a related field required; advanced degree preferred.
• Minimum of 2–4 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry.
• Strong knowledge of FDA regulations, ICH guidelines, and other applicable international standards.
• Experience with IND, NDA, ANDA, BLA, or device-related submissions is a plus.
• Excellent written and verbal communication skills.
• High attention to detail and strong organizational, planning, and time management abilities.
• Ability to work independently and collaboratively in a fast-paced, regulated environment.
• Regulatory Affairs Certification (RAC) is a plus.

Salary Range: The salary range for this position is $75,000 –  $95,000 a year ($36.00 – $46.00 per hour), based on experience. 

Interview Process:

• Initial Screening Call with TalentLNX
• Zoom Interview with Regulatory Affairs Leadership
• Final Onsite Interview with Regulatory Affairs Leadership

Equal Opportunity Employer: TalentLNX is committed to equal employment opportunity and prohibits discrimination and harassment of any kind. We are dedicated to building a diverse workforce and fostering an inclusive work environment where all employees and candidates are treated with respect and dignity. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other protected status under applicable law. We actively seek to recruit, develop, and retain talented individuals from diverse backgrounds, and we encourage all qualified candidates to apply for our job opportunities.