REGULATORY AFFAIRS ASSISTANT

REGULATORY AFFAIRS ASSISTANT

For our client – ABBVIE, a global biopharmaceutical company, we are looking for a driven professional for the mission of Regulatory Affairs Assistant.

Responsibilities
  • Assist in preparation and filing of regulatory submissions in a timely manner for all Company products marketed and/or registered in Bulgaria or new products intended to be marketed in Bulgaria. Follow up all steps for authorization/approval of these submissions.
  • Assist maintenance of existing pharmaceutical product marketing authorisations and monitor regulatory authority approval for the variations of these authorizations
  • Preparation and filling of the respective documentation related to all AbbVie promotional materials and donation procedures
  • Support all RA activities related to sampling procedures
  • Help in translation and preparation of SmPCs, PILs and labeling in accordance with legal and regulatory requirements
  • Provide and/ or manage required translation support
  • Manage training and communications to local Marketing, Sales and Medical personnel relating to SmPC/PIL changes prior to their implementation
  • Maintain internal regulatory files and product database in good chronological order
  • Maintain RA tracking systems
  • Responsible for regulatory document administration – updating lists and fillings; scanning and archiving regulatory correspondence. Process organizational and administrative routine tasks for the RA department.
  • Provide technical support to Regulatory Affairs Manager and Regulatory Affairs Specialist
  • Keep the assigned regulatory databases on the server up to date
  • Ensure compliance with statutory local, regional, [EU] and AbbVie corporate regulations
  • Responsible for execution of the training and education on a timely manner
  • Prepare monthly expense report
Requirements
  • University (business or scientific), preferably pharmacy, life sciences, chemistry or equivalent. University students of pharmacy, life sciences, chemistry, or equivalent will also be considered.
  • Proficiency in written / verbal English language
  • Computer literacy
Personal Characteristics
  • Thorough attention to detail and high standards of accuracy
  • Solution mindset, good problem-solving skills, and the ability to work to tight deadlines
  • Effective communications skills
  • Team player with the ability to work cross functionally
  • Team player with the ability to work cross functionally
  • Creative self-starter capable of working autonomously, with an interest in developing this role and continued training
The company offers
  • An opportunity to learn and develop oneself professionally in a leading international organization
  • Part-time role with 20 work hours per week
  • Competitive compensation

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