Regulatory Affairs Manager
Amgen
Employer Active
Posted 9 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Job Responsibilities:
- High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions.
- Maintain established products according to global and local regulatory plans.
- Update and maintain regulatory databases.
- Handle Health Authorities requests.
- Build and keep a highly professional relationship with the Medicines Agency.
- Support and interact with global regulatory affairs, QA, Market Access, Marketing (projects and product teams) and Sales to best support local and global strategy.
- Monitor future trends in regulatory affairs which are likely to affect AMGEN interest.
- Perform or facilitate audits to ensure compliance
Qualifications:
- A bachelor s degree in Pharmacy or any relevant field.
- Minimum of 6 years of regulatory experience in the pharmaceutical industry or with Health Authorities.
- Excellent current regulatory knowledge understanding of US FDA and EMEA regulatory guidelines.
- Advanced ability to interpret scientific data and to construct persuasive regulatory documents.
- Good communication skills, ability to work effectively in a matrix setup.
- Strong knowledge of regulatory life cycle maintenance.
- Having People Management experience is critical.
- An analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken.
- Strong communication and leadership skills with the ability to select, motivate, train, and develop staff to achieve company goals.
Desired Candidate Profile
Qualifications:
- A bachelor s degree in Pharmacy or any relevant field.
- Minimum of 6 years of regulatory experience in the pharmaceutical industry or with Health Authorities.
- Excellent current regulatory knowledge understanding of US FDA and EMEA regulatory guidelines.
- Advanced ability to interpret scientific data and to construct persuasive regulatory documents.
- Good communication skills, ability to work effectively in a matrix setup.
- Strong knowledge of regulatory life cycle maintenance.
- Having People Management experience is critical.
- An analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken.
- Strong communication and leadership skills with the ability to select, motivate, train, and develop staff to achieve company goals.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Regulatory Affairs Manager
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Amgen
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.