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
