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POSITION SUMMARY:

Responsible for coordination, preparation and compilation of complex regulatory submissions for an FDA regulated research, development and biologics manufacturing organization, in accordance with current laws, regulations and operating procedures. Resolves complex problems independently, efficiently, effectively and escalates critical matters appropriately. Requires critical thinking, time management and organizational skills, ability to multitask and consistently meet deadlines.

MAJOR RESPONSIBILITIES:

Product Safety and Quality

• Prepare and coordinate complex regulatory submissions. Ensure the collection and verification of necessary clinical documents for completed studies in preparation for regulatory submissions. Reviews documents prepared by lower level personnel.
• Recommend and design labeling revisions for review and submission to the FDA.
• Conduct regulatory review of complex change controls and executed validation protocols. Assign appropriate reporting categories.

Regulatory Resource for MassBiologics

• Review the Federal Register for items relevant to Biologics. Assess impact to MassBiologics activities and makes recommendations to management to ensure continued regulatory compliance.
• Resolve complex problems efficiently and effectively and ensure critical matters are escalated to management.

Regulatory Operations

• Recommend revisions to departmental SOPs for regulatory compliance. May review organizational SOPs as appropriate.
• Asess Regulatory Affairs operations and takes initiative to increase the efficiency of departmental operations.
• Supervise lower level personnel. 

REQUIRED QUALIFICATIONS:

• Bachelor's Level Degree
• Bachelor's or above in scientific discipline
• 5 - 10 years experience
• 5 or more years in a scientific discipline

• Exceptions could be made for a highly qualified candidate who has the education and skills, but experience is in a non-scientific discipline

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