Lead Specialist in Regulatory Operations
2 weeks ago
Senior Regulatory Operations Specialist
Overview:
The Senior Regulatory Operations Specialist plays a crucial role in the preparation, assessment, and submission of regulatory documentation to the Client Medical, Legal, and Regulatory (MLR) teams. This position is essential for supporting the pharmaceutical and healthcare sectors within the Princeton client base, overseeing the submission workflow for designated brands. Key responsibilities include acting as the primary submissions coordinator, ensuring adherence to submission timelines, and managing reference and asset repositories. The ideal candidate should possess over 4 years of relevant experience and demonstrate strong interpersonal and analytical abilities. Knowledge of agency submission protocols and MLR processes is advantageous.
Key Responsibilities:
- Delegate and manage tasks effectively among team members
- Collaborate with Project Management to guarantee timely submissions
- Adhere to Client submission protocols and utilize tools for optimal efficiency
- Organize submission documentation and maintain an up-to-date reference library
- Oversee the submission process from initiation through to final approval
Qualifications:
- Preferred 4+ years of experience in a comparable role
- Familiarity with agency submission protocols and MLR processes is a plus
- Exceptional interpersonal and problem-solving capabilities
- Ability to juggle multiple projects while working collaboratively
- Highly organized and detail-oriented with excellent communication skills
- Proficient in MS Office and other relevant software applications
About MRM:
MRM is a premier relationship marketing agency that delivers innovative solutions at the convergence of business, culture, and technology. With a global presence, MRM assists organizations in cultivating meaningful connections with their audiences. As a member of McCann Worldgroup and the Interpublic Group of Companies, MRM provides avenues for professional growth and collaboration across diverse regions.
MRM is committed to being an equal opportunity employer, promoting diversity and inclusion within the workplace.
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