Regulatory Affairs Specialist

Regulatory Affairs Specialist

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.

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

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

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

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

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

Regulatory Affairs Certification (RAC)

Good Clinical Practice (GCP) Certification

Good Manufacturing Practice (GMP) Certification

ISO 13485 Awareness (for medical device roles)

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.