Regulatory Affairs Sr Mgr

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