Regulatory Affairs Specialist

Job Description - Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist



Location: [City, State] / Remote / Hybrid


Job Summary


We are seeking a knowledgeable and detail-oriented Regulatory Affairs Specialist to support regulatory activities related to the development, approval, and lifecycle management of pharmaceutical, biotechnology, or medical device products. The ideal candidate will prepare regulatory submissions, ensure compliance with global regulatory requirements, and collaborate with cross-functional teams to facilitate timely product approvals and market access.


Key Responsibilities

• Prepare, compile, review, and submit regulatory documents to health authorities (FDA, EMA, MHRA, Health Canada, etc.).
• Maintain regulatory submissions, licenses, registrations, and product dossiers.
• Ensure products comply with applicable local and international regulatory requirements.
• Monitor changes in global regulations and communicate their impact to internal teams.
• Support the preparation of IND, NDA, ANDA, BLA, 510(k), PMA, CE Mark, and other regulatory submissions as applicable.
• Coordinate responses to regulatory agency questions and deficiency letters.
• Review product labeling, packaging, promotional materials, and artwork for regulatory compliance.
• Collaborate with Clinical, Quality Assurance, Manufacturing, R&D, and Medical Affairs teams.
• Maintain regulatory documentation, submission trackers, and compliance records.
• Participate in internal audits, regulatory inspections, and quality management activities.
• Support post-market regulatory activities, including product variations, renewals, and change control submissions.
• Ensure all regulatory activities follow Good Regulatory Practices (GRP) and company SOPs.

Required Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, Biology, or a related field.
• 2+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, medical device, or healthcare industry.
• Strong knowledge of FDA, EMA, ICH, ISO, and global regulatory requirements.
• Experience preparing and submitting regulatory documentation.
• Understanding of product lifecycle management and regulatory compliance processes.
• Excellent analytical, organizational, and documentation skills.
• Strong verbal and written communication skills.

Preferred Qualifications

• Master's degree in Regulatory Affairs, Pharmaceutical Sciences, or a related discipline.
• Regulatory Affairs Certification (RAC) is preferred.
• Experience with electronic submission systems such as eCTD.
• Knowledge of global product registration processes.
• Experience working with international regulatory agencies.

Technical Skills

• Regulatory Submission Management
• eCTD Publishing
• FDA Electronic Submissions Gateway (ESG)
• Document Management Systems (Veeva Vault, MasterControl)
• Microsoft Office Suite
• Quality Management Systems (QMS)
• Regulatory Information Management Systems (RIMS)
• Product Labeling Compliance

Soft Skills

• Strong attention to detail
• Analytical thinking
• Regulatory interpretation
• Problem-solving
• Time management
• Cross-functional collaboration
• Communication and presentation skills
• Project management
• Documentation and record management

Preferred Certifications

• Regulatory Affairs Certification (RAC)
• Good Clinical Practice (GCP) Certification
• Good Manufacturing Practice (GMP) Certification
• ISO 13485 Awareness (for medical device roles)

Benefits

• Competitive salary
• Health, dental, and vision insurance
• Paid time off and holidays
• Retirement savings plan
• Professional development and certification support
• Flexible work arrangements
• Employee wellness programs

This job description is optimized for candidates experienced in regulatory submissions, global regulatory compliance, product registration, regulatory strategy, and lifecycle management within the pharmaceutical, biotechnology, or medical device industries.