Regulatory Affairs Manager

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Regulatory Affairs Manager
 
  • Summary:
We are assisting our client, a pharmaceutical company, in searching a highly motivated and experienced Regulatory Affairs (RA) Manager. The RA Manager will play a critical role in ensuring compliance with regulatory requirements and guiding product registration processes for our pharmaceutical products.
 
  • Responsibilities:
  1. Develop and implement regulatory strategies for product registration, ensuring compliance with local and international regulatory requirements.
  2. Manage the preparation, submission, and maintenance of regulatory filings, including marketing authorization applications, variations, renewals, and annual reports.
  3. Collaborate with cross-functional teams to provide regulatory guidance and support throughout the product development lifecycle, including clinical development, manufacturing, and quality assurance.
  4. Review and interpret regulatory guidelines and communicate updates to relevant stakeholders to ensure compliance with changing regulations.
  5. Serve as the primary liaison with regulatory authorities and external partners, representing the company in regulatory interactions, meetings, and negotiations.
  6. Conduct regulatory assessments for new products, formulations, and labeling changes, and provide recommendations to mitigate regulatory risks.
  7. Monitor and track regulatory submissions and approvals, ensuring timely responses to regulatory queries and requests for additional information.
  8. Stay informed about industry trends, changes in regulations, and emerging technologies that may impact regulatory requirements or product development strategies.
  9. Provide training and guidance to internal teams on regulatory processes, requirements, and best practices.
 
  • Qualifications:
  1. Bachelor's degree in pharmacy, pharmaceutical sciences, life sciences, or related field. Advanced degree preferred.
  2. 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.
  3. Knowledge of international regulatory guidelines and standards, including ICH guidelines, FDA regulations, and EU directives.
  4. Proven experience in preparing and submitting regulatory filings for pharmaceutical products, including INDs, NDAs, BLAs, and MAAs.
  5. Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal teams and external stakeholders.
  6. Strong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet tight deadlines.
  7. Attention to detail and a commitment to maintaining high-quality standards in regulatory submissions and documentation.
  8. Ability to adapt to a fast-paced and dynamic work environment, with a proactive and solution-oriented mindset.
  9. Regulatory affairs certification (e.g., RAC) is a plus.
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