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Regulatory Affairs Specialist, MSI

The Position

Are you ready to take on a role where your regulatory expertise drives healthcare innovation forward? This role is responsible for achieving timely and successful product registrations in accordance with corporate and local strategies, collecting and sharing updates on new regulations and guidelines with the local RA team, and ensuring compliance with company regulatory policies, regulations, and procedures.

Tasks and Responsibilities:

1. Regulatory Planning and Submission

  • Manage regulatory tasks & projects, including attaining and maintaining product and operation licenses for assigned portfolio
  • Compile registration applications for assigned portfolio and ensure timely approval
  • Monitor submission progress and coordinate timely responses to health authority queries
  • Comply with corporate policies, regulations & procedures, including CCDS, CRC, and local change control processes

2. Regulatory Intelligence and Interaction

  • Collect new or updated local regulations from various sources
  • Share regulatory updates with the local RA team and ROPU
  • Communicate with regulatory authorities and local industry groups on regulatory issues

3. Cross-Functional Collaboration and Support

  • Provide regulatory consultation to local business stakeholders
  • Collaborate with internal teams and contribute to global initiative implementation

4. Quality and Compliance

  • Submit CCDS, CRC, renewals, PSURs, and other local variations in line with internal KPIs
  • Maintain regulatory database to reflect current registration status and requirements
  • Support local inspection readiness
  • Archive local regulatory submission documents

Requirements:

  • A degree in Pharmacy (preferred) or another degree in Life Sciences
  • Two to five years of experience in the pharmaceutical, medical device, or healthcare industry
  • Good knowledge of national drug regulations and procedures
  • Strong communication skills for internal and external interactions
  • Solid computer literacy and comfort working with database such as Q3+ and Prism
  • Analytical mindset with meticulous attention to detail

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