Summary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.
Roles and Responsibilities:- Regulatory Submissions: Prepare and submit regulatory documents for product approvals and amendments.
- Compliance Management: Ensure ongoing compliance with regulatory requirements.
- Regulatory Strategy: Develop strategies to achieve and maintain product approvals.
- Documentation: Maintain accurate and complete regulatory documentation.
- Liaison: Communicate with regulatory agencies and respond to queries.
- Risk Management: Identify and mitigate regulatory risks.
- Collaboration: Work with R&D, QA, Manufacturing, and Marketing teams.
- Regulatory Intelligence: Stay updated on regulatory changes and trends.
Qualifications Required:- Education: Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field. A Master's or certification in Regulatory Affairs is preferred.
- Experience: 3-5 years in regulatory affairs within the pharmaceutical industry.
- Knowledge: Familiarity with FDA, EMA, ICH guidelines, and product development processes.
Skills Needed:- Analytical Skills: Interpret and apply regulatory requirements.
- Attention to Detail: Accuracy in regulatory documentation.
- Communication: Effective interaction with regulatory agencies and teams.
- Problem-Solving: Address regulatory issues and challenges.
- Organizational Skills: Manage multiple projects and deadlines.
- Technical Skills: Proficiency in regulatory software.
- Interpersonal Skills: Collaborate with cross-functional teams and regulatory authorities.
