Associate, Regulatory Affairs
Associate, Regulatory Affairs
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Job Description
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RegulatoryJob Description
Join Amgens Mission of Serving Patients
At Amgen if you feel like youre 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. Join us and transform the lives of patients while transforming your career.
Associate Regulatory Affairs
What you will do
Lets do this. Lets change the world. In this vital role you will perform local coordination and execution of Regulatory submissions in compliance with corporate standards and local Regulatory requirements under the direction of a Senior Manager.
Responsibilities:
- Execution of the preparation delivery and electronic archiving of documentation for inclusion in local Regulatory submissions.
- Coordination and execution of Regulatory Affairs processes and deliverables in the local office.
Regional Specific Activities
- Ensure Regulatory submissions are made on time and meet Amgens corporate and local Regulatory requirements.
- Contribute to and implement filing plans where applicable.
- Review source text for country labelling.
- Disseminate relevant information to team(s) as appropriate.
- Participate in local Regulatory process improvement initiatives.
- Assist locally in Healthcare Compliance activities where applicable.
- Collate distribute exchange and review 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.
- Review translations for local Regulatory submissions.
- Partner with International Regulatory Leads (IRLs) to support the Regulatory development registration and lifecycle management of all Amgen molecules.
- Health Authority Interactions.
- Under general supervision interact with local health and Regulatory authorities for routine matters.
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The detail oriented professional we seek is a teammate with these qualifications.
Basic Qualifications:
Bachelors degree
Preferred Qualifications:
- 1 year of Regulatory affairs experience
- Regulatory Certificate
- Knowledge of Regulatory principles
- Working with policies procedures and SOPs
- Knowledge of national legislation and regulations relating to medicinal products
- Awareness of the registration procedures in Canada for clinical trial applications marketing applications post-approval changes and extensions
- Knowledge of drug development
- Scientific / Technical excellence
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Understanding of Regulatory activities and their touch points
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders
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 and make a lasting impact with the Amgen team.
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.
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.
.Required Experience:
IC
Employment Type
Full-Time
