Senior Associate Regulatory Affairs (CDMX)
Senior Associate Regulatory Affairs (CDMX)
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Job Description
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RegulatoryJob Description
Join Amgens Mission of Serving Patients
At Amgen if you feel like you are part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.
Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. We have proudly achieved certifications as Great Place to Work and Equidad MX. Join us and transform the lives of patients while transforming your career.
Senior Associate Regulatory Affairs (CDMX)
Live
What you will do
Key responsibilities include but are not limited to:
- Ensure regulatory submissions are made on time and meet Amgens corporate and local regulatory requirements.
- Contribute implement and execute the filing plan for Mexico where applicable.
- Preparereview & approve of source text for Mexico country specific labeling.
- Review & approve promotion and non-promotion materials
- Communicate relevant information to team(s) in advance
- Participate and give input in local regulatory process improvements initiatives.
- Collate distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
- Update maintain internal regulatory systems and tracking tools in accordance with internal policies and standard operating procedures.
- Develop & execute the local strategy to obtain the new Marketing Authorizations of the assigned business unit ensuring compliance with local and current regulations and procedures.
- Analysis of technical scientific and legal information to prepare dossiers of innovative products complying with all applicable requirements and guidelines avoiding preventions by the health authority (New Marketing Authorizations technical and administrative variations and renewals).
Collaboration
- Collate review and distribute Regulatory information & intelligence with other regulatory colleagues and cross functional teams on an ongoing basis.
- Partner where required with International Regulatory Leads (IRLs) CMC and other functions to support the regulatory strategy registration timelines and lifecycle management of all Amgen molecules.
- Ability to work with different cross functional teams to share discuss and negotiate the strategy and planning of submissions.
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:
- Masters degree O
- Bachelors degree and 2 years of experience in similar positions on a big pharmaceutical company Or
- Associates degree and 6 years of experience in similar positions on a big pharmaceutical company Or
- High school diploma / GED and 8 of experience in similar positions on a big pharmaceutical company.
- Proficiency in English both in oral and written communication.
Preferred Qualifications:
- Knowledge and experience in Mexican regulation relating to medicinal products and diverse portfolio of small molecules innovative biotechs biosimilars and orphan drugs.
- Knowledge of drug development Scientific / Technical Excellence.
- Experience in regulatory processes with Cofepris for a portfolio of innovative products: New Marketing Authorizations variations & renewals.
What you can expect of us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.
In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.
.Required Experience:
Senior IC
Employment Type
Full-Time
