SENIOR ASSOCIATE REGULATORY AFFAIRS (1-YEAR FIXED TERM)

Career Category Regulatory Job Description 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 (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 execute the filing plan for Mexico where applicable.
Prepare, review & 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.
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.
Master’s degree O Bachelor’s degree and 2 years of experience in similar positions on a big pharmaceutical company Or Associate’s 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.
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 career-development 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.
Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.
Join us.
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation..
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since , Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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