Regulatory Affairs Manager
Regulatory Affairs Manager
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Regulatory Affairs Manager
- Summary:
- Responsibilities:
- Develop and implement regulatory strategies for product registration, ensuring compliance with local and international regulatory requirements.
- Manage the preparation, submission, and maintenance of regulatory filings, including marketing authorization applications, variations, renewals, and annual reports.
- Collaborate with cross-functional teams to provide regulatory guidance and support throughout the product development lifecycle, including clinical development, manufacturing, and quality assurance.
- Review and interpret regulatory guidelines and communicate updates to relevant stakeholders to ensure compliance with changing regulations.
- Serve as the primary liaison with regulatory authorities and external partners, representing the company in regulatory interactions, meetings, and negotiations.
- Conduct regulatory assessments for new products, formulations, and labeling changes, and provide recommendations to mitigate regulatory risks.
- Monitor and track regulatory submissions and approvals, ensuring timely responses to regulatory queries and requests for additional information.
- Stay informed about industry trends, changes in regulations, and emerging technologies that may impact regulatory requirements or product development strategies.
- Provide training and guidance to internal teams on regulatory processes, requirements, and best practices.
- Qualifications:
- Bachelor's degree in pharmacy, pharmaceutical sciences, life sciences, or related field. Advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a strong understanding of regulatory requirements for drug registration and approval processes.
- Knowledge of international regulatory guidelines and standards, including ICH guidelines, FDA regulations, and EU directives.
- Proven experience in preparing and submitting regulatory filings for pharmaceutical products, including INDs, NDAs, BLAs, and MAAs.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal teams and external stakeholders.
- Strong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet tight deadlines.
- Attention to detail and a commitment to maintaining high-quality standards in regulatory submissions and documentation.
- Ability to adapt to a fast-paced and dynamic work environment, with a proactive and solution-oriented mindset.
- Regulatory affairs certification (e.g., RAC) is a plus.