Drug RA Manager

Job Summary:
We are seeking a highly motivated and detail-oriented Drug Regulatory Affairs Specialist to join our growing team. In this role, you will be responsible for managing the drug registration process for our innovative pharmaceuticals across Southeast Asia, with a primary focus on Singapore and Malaysia. You will work closely with internal teams and regulatory agencies to ensure timely and accurate submissions. Additionally, you will stay up-to-date on evolving regulatory requirements in the region and proactively identify and address potential issues.

Responsibilities:

1. Document Preparation and Submission:
   • Lead the preparation and submission of drug registration applications, ensuring compliance with regulatory guidelines in Singapore and Malaysia.
   • Collaborate with internal teams to gather necessary documentation for registration submissions.
   • Ensure adherence to local regulatory requirements throughout the application process.
2. Manage Drug Registration Process:
   • Develop and execute regulatory strategies for drug registration submissions to health authorities in Southeast Asia, particularly Singapore's Health Sciences Authority (HSA) and Malaysia's National Pharmaceutical Regulatory Agency (NPRA).
   • Oversee the drug registration process, including obtaining marketing authorizations and licenses.
   • Interact with regulatory agencies to address questions and clarifications during the registration review process.
3. Regulatory Oversight:
   • Proactively monitor regulatory changes and updates in Singapore, Malaysia, and other Southeast Asian markets, assessing their impact on existing and planned programs.
   • Prepare and present regulatory documentation to internal stakeholders, including senior management.
4. Record Keeping and Progress Tracking:
   • Maintain detailed records and track the progress of drug registration applications.
   • 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 in Singapore and Malaysia during the drug registration process.
   • 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 Quality Assurance and Manufacturing, to align regulatory activities with overall business objectives.
   • Provide regulatory guidance to support the development and implementation of 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 regulatory guidelines and requirements in Singapore, Malaysia, and other Southeast Asian countries.
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.