Associate Specialist Regulatory Affairs at MSD
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 MSD 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.
Experience in Regulatory Affairs in similar position is preferred.
High sense of customer orientation.
High sense of team work ancollaboration.
Advanced negotiation skills.