Amgen Regulatory Affairs Manager in Istanbul, Turkey
Ensure regulatory compliance with a focus on patient safety.
Define the regulatory strategy in line with internal and external needs
Create opportunities to shape the future of Amgen
Execute the approved regional strategy for assigned programs.
Advise the Global Regulatory Team (GRT) on regional considerations in developing strategy.
Ensure the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
Plan and manage regulatory submissions for products within Amgen’s portfolio in compliance with global filing plans and local regulatory requirements.
Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Provide content guidance for regional regulatory documents and meetings in accordance with GRT strategy.
Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan).
Manage the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
Obtain and maintain Marketing Application approvals including Response to Questions (RTQs)
Communicate regulatory strategies within team (e.g. GRT, local affiliates).
Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments).
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
- Participates in local industry and trade association groups relating to Amgen business activities and Regulatory Affairs.
Pharmacist, Chemical Engineer or Chemist
Scientific Degree and demonstrated experience in a similar role
Working with regulatory principles, policies, procedures and SOP’s
Knowledge of legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.
Communication skills – both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Minimum 8 years experience in similar position
Experience interacting with regulatory agencies
Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Subject matter expertise and technical excellence
Advanced negotiation, collaboration, persuasion, communication and relationship building skills
Role model for Amgen Values
Experienced manager of large scale projects
Accomplishes business results through professional employees and skilled technical staff
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.