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CMC Regulatory Change Control Support
Ref No.: 18-07710
Location: Waltham, Massachusetts
Start Date / End Date: 07/09/2018 to 07/04/2019
The manager will take recent grads with a Science background.

Regulatory CMC opportunity to manage change controls for biological products within the hemophilia franchise. This role will support the Change Control Owner and Reg CMC Lead to ensure that change controls are completed per Change Control and Regulatory procedures as well as Regulatory Submission Strategy. A key responsibility is gathering and capturing country-level assessments and maintaining submission records in various systems.
RESPONSIBILITIES
• Will interact with Regulatory CMC leads to ensure accurate understanding the scope of the change controls and the strategy of regulatory submissions
• Responsible for gathering and reporting country level assessments to ensure they are completed accordingly (e.g. target dates)
• Responsible for gathering overall impact for Change Controls from the Reg CMC lead and entering the impact into the Quality Management System
• Responsible for entering country level assessments in the Regulatory Management System
• Responsible for completing tasks (e.g. Change Actions) related to the assessments in the Quality Management System
• Responsible for maintaining the state and status of submissions in the Regulatory Management System
• Responsible for reporting on the status of country level assessments in the Regulatory Management System to the Regulatory CMC leads to ensure that assessments are completed accordingly (e.g. target dates)
• Responsible for updating other Change Control and Regulatory artifacts as deemed necessary.
QUALIFICATIONS

• A minimum of 3 years in the Pharmaceutical Industry including a minimum 1 years of experience within regulatory CMC (Biologics) preferred
• Demonstrate excellent communication skills.
• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
• Demonstrate effective cross-cultural awareness and capabilities.
• Some direct experience in interfacing with relevant regulatory authorities.
• Some Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
• Some knowledge and understanding of applicable regulations.
• Some experience with Change Control and Regulatory systems

EDUCATION:

• BA/BS/University degree required. Life/Health Sciences preferred.