Regulatory Affairs
12 hours ago
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.
- 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.
- 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.
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