Amgen Global Regulatory Operations – Regulatory Data & Analytics – Senior Associate in Lisbon, Portugal
Global Regulatory Operations – Regulatory Data & Analytics – Senior Associate
The ACCP will be temporarily located at the Maleo – Saldanha, Av. da República 18, 1050-191 Lisbon. We’re already gearing up to have our brand-new permanent office ready in the vibrant city center of Lisbon by the spring of 2022.
All, or a subset of the following:
- Monitoring data quality/health, including collaboration with other internal functions to maintain planned submission and approval dates
- Updating the Regulatory Submissions and Document Information Management System (RSDIMS)
Metrics compilation and analysis
Liaison with internal customers to improve efficiencies within RDA and other functional areas
Manages requests within the Regulatory Intake System to comply with data management of a GMP system
Maintain Regulatory document management and tracking systems.
Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
Responsible for maintaining the on-site hard copy Regulatory archive and overseeing incoming/outgoing off-site Regulatory document storage.
Point of contact between Regulatory Representatives/CMC and publishing teams.
Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions.
Ensuring Regulatory compliance with SOPs and Regulatory authorities
Provide training, mentoring and support to RDA team members and other functional areas, including vendors.
Collaboration with external partners/outsourced CROs
Run 1572 forms for FDA submission.
Knowledge and Skills:
Working in teams
Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
Complex understanding of the Veeva Vault system
Good written and verbal communication skills
Independent time management and prioritization skills
Work efficiently with little support and minimal to no supervision
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
Critical thinking skills
Appropriate software skills as required
Education & Experience (Basic):
Bachelor’s degree and 2 years of directly related experience
Associate’s degree and 6 years of directly related experience
High school diploma / GED and 8 years of directly related experience
Education & Experience (Preferred)
Experience in an operationally-focused role within Regulatory Affairs
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.