.HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are.
At Amgen, our shared mission—to serve patients—drives all that we do.
It is key to our becoming one of the world's leading biotechnology companies.
We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide.
It's time for a career you can be proud of.Join us.SENIOR ASSOCIATE REGULATORY AFFAIRS LIVEWhat you will do In this role, you will support marketed products and investigational in vitro diagnostic medical devices to be used in combined trials under the supervision of an experienced Local Regulatory Lead.
The key responsibilities will be:Assist in aligning local regulatory requirements with Amgen's corporate standards.Provide national input to and execute regulatory strategies.Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.Enable regulatory agencies interactions.Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and execution for IVD performance studies in accordance with national regulatory requirements.Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.Create, review, and approve source text for country labeling, and own the country artwork based on source text.Act as the point of contact with regulatory agencies in fulfilling local obligations.Participate/contribute to local agency interactions and their preparation.Work closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.Exchange regulatory information and intelligence with other regulatory colleagues and cross-functional teams on an ongoing basis and provide advice on local regulatory considerations/regulations in a timely manner.Participate in local regulatory process improvements, initiatives, and training.What we expect of you We are all different, yet we all use our unique contributions to serve patients.
What we seek in you as an experienced professional, are these qualifications and skills:Qualifications Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field.Master's degree in Pharmaceutical Industry desirable.Fluency in Spanish and English languages.
Knowledge of Portuguese language is desired.Depth of knowledge of legislation and regulations relating to medicinal products and in vitro diagnostic medical devices.2 or more years of relevant work experience within the pharmaceutical industry.Skills Ability to work in teams.Attention to detail.Prioritization skills.Solution-oriented problem-solving skills