Regulatory Affairs Sr Mgr at Amgen

Career Category

Regulatory

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