Associate Specialist vacancy | Regulatory Affairs vacancy at MSD | 1 year of experience
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Basic Functions & Responsibility Essential functions include, but are not limited to:
Under the direction of the Regulatory Manager/Senior Regulatory Specialist, the incumbent:
· Executes regulatory activities according to company plans.
· Handles timely submission and follow-up of post-approval labeling and CMC variations.
· Ensures permanent compliance to local regulatory requirements and to our company's policies and procedures.
· Ensures that local Quality activities are completed according to company Quality Systems and all legal requirements are met.
Qualifications and Skills Required:
· Degree of Pharmacy, Chemistry, Biology or equivalent
· Minimum 1 year of experience in Regulatory Affairs in similar position is a must
· Leadership competencies
· High sense of customer orientation
· High sense of collaboration
· Advanced negotiation skills
· English fluency