Responsibilities:
1. Lead Document Preparation and Submission:
· Lead the preparation and submission of CTA/IND applications, ensuring compliance with Singapore and international regulatory guidelines, especially FDA.
· Collaborate with internal teams to gather necessary documentation for IND submissions.
· Ensure compliance with regulatory guidelines and requirements throughout the application process.
2. Manage Drug Registration Process:
· Develop and execute regulatory strategies for drug registration submissions to health authorities.
· Oversee the drug registration process, including obtaining marketing authorizations and licenses.
· Interact with regulatory agencies to address questions and clarifications during the clinical trial application process and registration review process.
3. Regulatory Oversight:
· Proactively monitor regulatory changes and updates, assessing their impact on existing and planned programs.
· Prepare and present regulatory documentation to internal stakeholders, including clinical teams and senior management.
4. Record Keeping and Progress Tracking:
· Maintain detailed records and track the progress of clinical trial applications and registrations.
· Work closely with internal teams to ensure that regulatory documentation supports product development and commercialization efforts.
· Conduct regulatory assessments and gap analyses to identify and address compliance issues.
5. Risk Management:
· Identify and manage potential regulatory risks and proactively develop mitigation strategies.
6. Communication
· Act as the primary point of contact for regulatory agencies during filing of clinical trial approval applications and drug registration processes.
· Provide timely updates to internal stakeholders on the status of regulatory submissions and approvals.
· Participate in regulatory meetings, addressing queries and providing necessary information.
7. Cross-functional Collaboration:
· Collaborate with cross-functional teams, including Clinical Development, Quality Assurance, and Manufacturing, to align regulatory activities with overall business objectives.
· Provide regulatory guidance to support the development and implementation of clinical and nonclinical development plans.
Qualifications:
1. Master's degree in Regulatory Affairs, Pharmacy, Pharmacology, or a related field.
2. Minimum of 3 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
3. Strong understanding of local and international regulatory guidelines for clinical trial approval and drug registration, especially FDA.
4. Excellent written and verbal communication skills, with the ability to communicate complex regulatory information clearly and concisely to diverse audiences.
5. Proven ability to manage multiple projects simultaneously and meet deadlines.
6. Detail-oriented and highly organized, with strong analytical and problem-solving skills.
7. Ability to work independently and as part of a team.
8. Proactive and self-motivated, with a passion for regulatory affairs.
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