What are the responsibilities and job description for the Regulatory Affairs Operations Specialist 2 position at Cook Group?
Overview
The Regulatory Affairs Operations Specialist role supports the global Regulatory Affairs Operations Director and cross functional teams in the development, implementation, communication and coordination of all Regulatory Affairs data and documents supporting digital transformation projects. This position leverages operational skills to support the continuous improvement efforts of Regulatory Affairs processes. This position leverages regulatory affairs knowledge in the submission, registration processes to support global regulatory functional goals are met.
Responsibilities
• Support Regulatory Operations and cross-functional teams in the planning and tracking of registration data and submission ready documents migrated into the Veeva RIM system.• Review documents and edit their formatting and style to meet regulatory guidelines and compliance with departmental Procedures and style guidelines. • Update and review trackers for regulatory submissions, correspondence, health authority commitments to ensure all regulatory records are “audit ready” for migration into the Veeva RIM system.• Organize and archive new and historic regulatory documents in Microsoft SharePoint and Veeva Vault Submissions Archive• Contribute to the development and review of Procedures, Work Instructions, and guides relevant to Regulatory Operations• Provide general administrative support such as updating regulatory metric trackers, taking meeting minutes, creating content for training.• Participates in department projects that improve the department systems and processes.• Assist RA in developing and implementing improvements and changes to RA processes and systems • Must work and interact effectively and professionally with and for others to achieve company goals• Must strictly adhere to safety requirements• Maintain regular and punctual attendance• Must maintain company quality and quantity standards• Must have effective oral and written communications throughout various levels of the global organization • Ability to work in collaborative and independent work situations and environments with minimal supervision• Ability to remain calm and receptive in fast paced situations
Qualifications
• Bachelor’s of Science degree in a relevant scientific or life sciences discipline required (or equivalent in experience)• Minimum 2 plus years of Regulatory Operations experience required• Experience in managing and publishing regulatory submissions for investigational or marketed products to global regulatory authorities • Strong working knowledge of Microsoft Word, publishing software, and Veeva Vault RIM preferred• Knowledge of industry standards, regulations, guidelines related to regulatory submissions for medical devices• Ability to work independently with minimal supervision or direction• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities• Excellent written and verbal communication skills, including ability to write clearly and present information effectively• Exceptional organizational skills and the ability to think critically and independently and problem solve on tight deadlines• Detail-oriented with the ability to understand the overall strategy of multiple projects/programs• Experience with multiple cloud-based RIMS systems (Veeva, etc.) in Regulatory, Clinical and Content Management preferred
Physical Requirements:- Works under general office environment conditions.- Sits for extended periods- Requires close visual acuity when working with computers, etc.- Requires occasional early morning or late evening teleconferences- Travel may be required.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
