The Regulatory Associate, under direction of an EURL or supervisor, will assist in the creation and maintenance of regulatory strategies, submissions and other documents.
This role provides support to the Therapeutic Area team which facilitates product development and global registration to achieve the desired regional labeling and registered details by developing and executing regulatory strategies and effective regulatory agency interactions.
- Assist EU Regulatory Lead with pre-filling activities (eg core CTA/IMPD development and submission, support for pre-MAA Filing, regulatory authority meeting preparations)
- Provide and maintain CTA/MA documentation (eg MAA, IMPD, substantial amendments, PDCO annual reports, etc) in collaboration with EU Regulatory Lead.
- Create and maintain product regulatory history documents through IMR/RISE and appropriately archive all regulatory documents and agency communications.
- Reviw regional component of the Global Regulatory Plan and provide input to operational deliverables.
- Ensure compliance via timely submissions to regulatory agencies.
- Collaborate with CROs/partners to support site initiation.
- Support EURL in review of promotional materials for regional commercial activities.
- Coordinate collection of functional documents in support of regulatory applications.
- As appropriate, participate in GRT to support execution of regulatory strategy.
- Coordinate QC of regulatory documentation (eg briefing packages).
- Provide primary authorship to routine regulatory correspondence (eg annual reports, investigator packages).
- prepare regulatory packages and cross-reference letters to support investigator initiated studies.
- Approve drug shipment for Amgen and investigator initiated studies.
- Complete regulatory forms to support agency communications (eg EudraCT).
- Provide regulatory support to commercial, medical and clinical departments through cross-functional interactions in brand and therapeutic area teams.
- Respond to specific requests from and communicate relevant issues to GRT.
- Develop regulatory position with teams.
- Activiely support regulatory compliance.
- Support the development and execution of GRT goals.
- Maintain an ongoing awareness of developing regulations and work with LAOs to ensure all requirements are met.
- Support process improvement initiatives, standards development and metrics. Assist in template develoopment and maintenance.
- Attend relevant training to broaden skills and knowledge and help develop training materials on topics for intra-functional training.
- May act as buddy for new staff or share knowledge and experience on ongoing basis with less experienced staff.
- Act within Amge financial policies and request approprate money for filings.
- Work in compliance with all company controlled documents assigned to the function.
Knowledge and Skills:
- Strong communication skills - both oral and written.
- Organisational skills and developing regulatory project management skills.
- Ability to work with some autonomy within restricted activities.
Associate's degree and 4 years of directly related experience
High school diploma / GED and 6 years of directly related experience.
Experience in European and/or Emerging Markets regulatory affairs, supporting routine CTA submissions for either biotechnology or chemically-derived products and pre-filing activities for MA submissions.