Overview:
We are seeking a knowledgeable Regulatory Affairs Specialist to join our consultancy in Cambridge, MA. This role involves providing expert regulatory guidance and support to our clients in the life sciences industry, focusing on regulatory compliance and strategies.
Responsibilities:
Collaborate closely with clients to provide expert regulatory guidance and support in the development of regulatory strategies for their products or initiatives.
Assist in preparing and reviewing regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Pre-Market Approval (PMA), and other regulatory filings as required.
Conduct regulatory assessments and gap analyses to ensure compliance with FDA, EMA, and other global regulatory standards.
Stay updated with evolving regulatory guidelines and changes, interpreting and communicating these updates to clients to facilitate informed decision-making.
Support clients during regulatory agency inspections, audits, and interactions, providing guidance and assisting in the preparation and response to inquiries.
Requirements:
Bachelor’s degree in a scientific discipline, life sciences, pharmacy, or related field (advanced degree preferred).
2+ years of experience in regulatory affairs within the life sciences industry, preferably in a consultancy setting.
Profound knowledge of FDA and international regulatory requirements, guidelines, and procedures.
Demonstrated experience in preparing regulatory submissions and interacting with regulatory agencies.
Strong attention to detail, analytical skills, and problem-solving abilities.
Excellent communication and interpersonal skills to collaborate effectively with clients and internal teams.
Benefits:
Competitive compensation package.
Opportunities for professional growth and development in a leading consultancy.
Collaborative and innovative work environment in the heart of Cambridge, MA.
Health and wellness programs.
Potential for remote work or flexible scheduling (if applicable).