23 ene
Amgen
Xico
.
**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.
**Regulatory Affairs Manager** (1-year fixed term)**:**Live****What you will do****Key responsibilities include,
but are not limited to**:- Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.- Contribute implement, and complete the filing plan for Mexico where applicable.- Review & approval of source text for country labeling, and owners of country artwork based on source text.- Review and approval of promotion and non-promotion materials.- Contribute to and implement filing plan for Mexico where applicable.- Supervise changes in local trade Association, Code and national legislation and forward information to local /regional/reg global groups and feedback into strategy in a timely manner (where applicable)- Assist locally in Healthcare Compliance activities where applicable.- Input into the affiliate / local office compliance framework to ensure complies with local codes and legislation and Amgen policies.- Sharing relevant information to cross functional team as appropriate.- Participate in local regulatory process improvements initiatives and training.- Where applicable lead all aspects of external vendor/contractor relationships.- Close collaborating with Global Regulatory Team to support local planning and execution for New Marketing Authorizations and administrative and major technical variations in accordance with national legal and regulatory requirements.- Exchange regulatory information & intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.- Partner where required with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.- Under general supervision participates in regulatory activities to ensure effective local agency interactions.
**Win**:**What we expect of you**We are all different, yet we all use our unique contributions to serve patients.
The professional we seek has these qualifications
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.