AbbVie Associate Regulatory Affairs Manager in Beijing, China
Associate Regulatory Affairs Manager
China, Beijing, Beijing
To deliver successful regulatory submissions and approvals, to ensure that products within an assigned portfolio comply with local regulatory requirement and to support the commercialisation of products through participation in local brand teams.
Key Responsibilities Include:
Planning and management of major submissions to register NCEs or new indications to existing products within an assigned product portfolio.Planning and management of variation applications for assigned products.
Perform and manage day-to-day product registration operations and ensure timely completion of the registration tasks assigned, in compliance with regulations, guidelines and internal processes.
Maintaining regulatory records for assigned product portfolio in compliance with local and global procedures.Manage interactions with TGA and Medsafe and maintain productive working relationships with these authorities to optimize regulatory outcomes.
Develop and maintain an up-to-date working knowledge of the compounds, diseases and competitors relevant to the product portfolio.Maintain good working knowledge of relevant regulatory guidelines and procedures.
Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager.Maintain excellent cross-functional relationships with key global regulatory personnel and affiliate medical, commercial, operations and market access contacts to ensure cohesive stakeholder management and affiliate support.
Support the commercialisation of products through participation in local brand teams.Provide comment on TGA/Medsafe consultation documents as required.
Attend regular departmental meetings with manager/supervisor to build in continuous feedback mechanisms.
Meet the requirements of ISO and any other departmental audits by complying with all relevant Regulatory and Quality policies and procedures to ensure the Quality and Regulatory objectives of the business are met
Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures and work practices with the intent of preventing or minimising accidental exposures to self, colleagues and/or the environment
Minimum 3-5 years regulatory affairs experience within the ANZ environment, which includes the preparation and negotiation of major submissions for new chemical/biological entities and/or registration of new indications.Experience with Class I and II device inclusions, desirable, but not essential
Skills:A commercial focus and a desire to contribute to the overall success of the businessAbility to work autonomously as well as part of a cross functional team
Well organized with an ability to meet deadlines and achieve goalsGood negotiation skills
Good oral and written communication skillsGood attention to detail
Ability to critically appraise dataWell-developed technical regulatory skills
Proven ability to provide innovative solutions to business challengesAbility to work in a high paced environment
Good proficiency for Microsoft Office (Word, Excel, PowerPoint)