Regulatory Affairs

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.
  
  

Skills: regulatory compliance,risk assessment,regulatory affairs,regulatory submissions,regulatory requirements