Amgen Regulatory Affairs Manager in Bangkok, Thailand

Responsibilities:

Strategic and Execution

  • Perform local regulatory submissions of new biologic/chemical entity applications;

  • Maintain life cycle management activities, liaise with cross-functional teams on RA/QA/Supply issues;

  • Ensure regulatory submissions are made on time and meet Amgen's corporate and regional regulatory requirements;

  • Review & approval of source text for country labeling, and owners of country artwork based on source text;

  • Review and approval of promotion and non-promotion materials;

  • Contribute to and execute filing plan for their country where applicable;

  • Monitor changes in local trade Association, Code and national legislation and forward information to local reg groups and feedback into strategy in a timely manner;

  • Help to set up a local office in Singapore in the near future.

Collaboration

  • Collaborate with Global Study Operations (GSO) to support regional planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate);

  • Exchange regulatory information & intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on regional regulatory considerations in a timely manner;

  • Partner where required with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules;

HA Interaction

  • Under general supervision participates in regulatory activities to ensure effective regional agency interactions;

  • Act as a contact where appropriate with regulatory agencies in fulfilling regional obligations by product assignment.

i. Qualification & Skills:

  • Bachelor above degree with directly related experience;

  • Good communication skills - both oral and written;

  • Ability to understand and communicate scientific/clinical information;

  • Understanding of regional regulatory activities and how they affect projects and processes

  • Ability to input effectively on multi functional teams;

  • Ability to anticipate and prevent potential issues;

  • Understanding of drug development;

  • Working with policies, procedures and SOP's;

  • Understanding of regulatory activities and their touch points;

  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome;

Competencies

  • Planning and organizing

  • Managing multiple activities

  • Problem solving abilities

  • Setting priorities

  • Action orientated

  • Working in teams

  • Presentation Skills

  • Managing diversity

  • Managing and measuring work

  • Negotiation skills

  • Regulatory submissions / compliance experience (Preferred)