Regulatory Affairs Manager

7 days ago

Klang, Selangor, Malaysia Monroe Consulting Group Full time

Executive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading provider of pharmaceutical services globally. Our distinguished client is looking for an ambitious and experienced professional to join the team as a Regulatory Affairs Project Manager (SEA) to ensure that the organisation meets its regulatory compliance requirements for new product registrations and variations to existing registrations within assigned portfolio and territories. This person will report to the Regional Regulatory Affairs Manager (APAC) and will be based in Selangor, Malaysia.

Job Responsibilities:

Portfolio Management:

  • Prepare regulatory submissions for both new registrations and existing products (maintenance applications) in a cost efficient and timely manner, ensuring there are minimal delays or interruptions to market supply.
  • Prepare regulatory submissions in accordance with relevant local legislation, regulations and corporate requirements in an efficient manner.
  • When preparing a submission, collaborate with relevant internal and external stakeholders as per internal processes. Ensure stakeholder review correspondence and approval is recorded.
  • Critically analyse, identify discrepancies, and provide recommendations (gap analysis) on data packages to ensure they comply with agency legislation and guidelines prior to submission.
  • Collaborate with Marketing, Medical Affairs and Pharmacovigilance (PV) to ensure product mock-ups and product labels (e.g. PI and CMI) are prepared and submitted in accordance with relevant legislation and regulations.
  • Initiate, build and maintain strong internal (local and global) and external (partners, clients and agencies) relationships to ensure compliance and support objectives of the organisation.

Technical Expertise & Compliance:

  • Provide regulatory guidance to internal stakeholders through advice on regulatory requirements.
  • Participate and contribute to cross-functional team business planning & strategy.
  • Ensure knowledge of the current regulatory environment, regulations and associated guidelines is maintained and developed, applying this knowledge to day-to-day activities.
  • Attend relevant industry conferences to expand knowledge of relevant therapeutic areas.
  • Maintain up-to-date knowledge of local regulatory guidelines and legislation, and the company's Quality Management System and Group Policies while always ensuring compliance.
  • Ensure Company related activities comply with relevant Acts, legal demands and ethical standards.

Knowledge & Relations:

  • Provide regulatory support and expertise to other areas of the Company and global/regional product development and regulatory teams.
  • Drive operational regulatory projects when necessary.
  • Engage in discussions with regulatory authorities concerning regulatory issues with registered products.

eCTD Publishing:

  • Lead project for initiation of eCTD publishing in Singapore due to change in regulatory requirements.
  • Complete relevant training for Extedo publishing software.
  • Develop a solid understanding of eCTD publishing of regulatory dossiers for new product registrations and variations to existing products in accordance with local agency requirements.

Administrative Tasks:

  • Ensure documentation is up-to-date and compliant with standard processes and formats.
  • Ensure Regulatory files/library/storage/archive for assigned portfolio are always maintained for easy access and retrieval of registration dossiers and correspondence files.
  • Deliver required reports within designated timeframes.
  • Drive and oversee projects, with a collaborative approach.
  • Ensure communication with staff & management using proper channels.
  • Manage workload and priorities to meet company objectives and Regulatory Agency Timeframes.
  • Proactively inform management and internal stakeholders of any conflicts or delays in projects.
  • Promptly notify PV/Medical Affairs team of all adverse reactions reported on company's products, in line with company policy/legislative requirements.

Requirements:

  • 5+ years' experience in Regulatory Affairs within the pharmaceutical, fmcg or cosmetics industries.
  • Demonstrated experience in a regulatory role.
  • Bachelor's Degree/Master's in Medical Science/Pharmacy/Biotechnology or any relevant medical field.
  • Must-have working knowledge and experience in the Health Sciences Authority (HSA) and National Pharmaceutical Regulatory Agency (NPRA). Other APAC regulatory agencies such as HK-DOH, and TW-FDA is desirable.
  • Possesses strong written, verbal and interpersonal communication skills.
  • Team-oriented, will a collaborative approach to the delivery of tasks and projects.
  • Excellent organisational skills and ability to prioritise regulatory tasks and projects.
  • Self-motivated with a sense of urgency.
  • Ability to work independently and to handle multiple tasks in a fast-pace and constantly changing environment.
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