Regulatory Affairs Manager - Ciudad de México - Amgen

Amgen

Empresa verificada

Ciudad de México

hace 4 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

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 nonpromotion 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.

Basic Qualifications:

Doctorate degree Or
Master's degree and 3 years of experience in similar positions on a big pharmaceutical company
Bachelor's degree and 5 years of experience in similar positions on a big pharmaceutical company Or
Associate's degree and 10 years of experience in similar positions on a big pharmaceutical company Or
High school diploma / GED and 12 of experience in similar positions on a big pharmaceutical company.
Proficiency in English, both in oral and written communication.

Preferred Qualifications:

Knowledge of Mexico legislation and regulations relating to medicinal products such as biotechnological, biologics, and small molecules.
Regulatory principle.
Working and alignment with policies, procedures and SOP'.
Awareness of the registration procedures in Mexico for New Marketing Authorizations, post approval changes, extensions and renewals.
Team work.
Ability to understand and communicate technical/scientific information.
Ability to anticipate and prevent potential issues.
Understanding of regulatory activities and their touch point.
Ability to resolve conflicts/challenges and develop a course of action leading to a beneficial outcome.
Cultural awareness and sensitivity to achieve results across country.

THRIVE

Some of the vast rewards of working here:

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

Full support and careerdevelopment resources to expand your skills, improve your expertise, and maximize your potential along your career journey.
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor.

for a career that defies imagination

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.