Career Category
Regulatory
Job Description
Job Description
- Apply, obtain and maintain regulatory approvals for products within Amgen’s portfolio, including CTNs, MAAs, renewals, variations, and other life cycle management activities.
- Ensure all regulatory submissions are delivered on time and comply with Amgen corporate standards as well as local regulatory requirements.
- Develop and implement product related regulatory strategies, Regulatory Affairs processes, and activity plans in accordance with national legislation and regulatory requirements
- Lead interactions and negotiations with Regulatory Authorities to facilitate and optimize regulatory approvals.
- Participate the in the local implementation of key Regulatory initiatives and projects.
- Maintains an awareness of emerging legislation, regulatory policies, and technical Regulatory guidance relating to Amgen’s pipeline and product portfolio.
- Provide regulatory support to Therapeutic Areas and Scientific Affairs activities.
- Where applicable, oversee external vendors and contractors.
- Feedback on relevant Regulatory Intelligence and insights to International Regulatory Affairs
Knowledge and Skills
- Strong regulatory expertise in national, MRP, centralized procedures, biotechnology products, and medical devices
- Proven experience in interacting with regulatory authorities
- Solid understanding of policies, procedures and SOPs
- In-depth knowledge of national legislation and regulations relating to medicinal products
- Understanding of Europe and US regulatory pathways, including MAAs, variations, extensions, and renewals
- Knowledge of drug development
- Experience managing complex regulatory projects
- Demonstrated scientific and technical expertise
- Strong leadership
- Excellent verbal and written communication skills
- Effective team work and collaboration skills
- Strong negotiation and stakeholder management abilities
- Ability to proactively identify, anticipate, and mitigate potential issues
Basic Qualifications
- Doctorate degree and a minimum of 5 years of directly related experience; or
- Master’s degree and a minimum of 8 years of directly related experience; or
- Bachelor’s degree and a minimum of 12 years of directly related experience
Preferred Qualifications:
- Experience working in MNCs,
- Experience in Biologics
- Experience in Oncology
- Experience in medical devices registration field
- Proficiency in multiple languages
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