Associate Specialist vacancy | Regulatory Affairs vacancy at MSD | 1 year of experience
Job Description
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