Regulatory Affairs Associate - Cook Pharmica
Cook Medical 37 reviews - Bloomington, IN

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Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) with process development, clinical and commercial bulk drug substance manufacturing, formulation development, clinical and commercial parenteral drug product manufacturing, including liquid and lyophilized vials, prefilled syringes and secondary packaging, and an array of support services all at a single facility in Bloomington, IN. Founded in 2004, Cook Pharmica is a division of Cook Medical, the world's largest privately held medical manufacturing company.

Primary Function
To serve as a regulatory liaison and expert to clients and internal functional departments.

Essential Job Functions/Duties
• Review and update facility drug master file(s)
• Prepare accurate and quality documentation for client regulatory submissions
• Provide regulatory guidance and support for development and production activities
• Maintain awareness of changes in FDA requirements for effective regulatory submissions
• Review regulatory documents to ensure compliance with FDA requirements, agreements and regulations
• Serve as regulatory liaison with the FDA and other regulatory agencies for assigned projects
• Provide written documentation of all interactions with regulatory agencies
• Develop and implement regulatory strategies to facilitate client relationships, as well as serve as a regulatory resource for clients
• Must work and interact effectively with and for others to achieve
company goals
• Must strictly adhere to safety requirements
• Must meet company attendance requirements
• Must maintain company quality and quantity standards
• Must have effective oral and written communications throughout various
levels of the 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

Minimum Work Experience/Educational Requirements
• Good organizational and planning skills
• Strong computer skills
• Experience with facilities inspections preferred
• Strong written, verbal, and interpersonal communication skills
• Ability to work independently, as well as in close collaboration with others
• Bachelor’s degree in life sciences or equivalent experience
• 2-4 years experience in regulatory affairs or related field in biopharmaceutical or parenteral manufacturing preferred
• Required to sign confidentiality and non-compete agreement

Physical Requirements/Work Environment
• Must be able to lift/push/pull up to 30 pounds occasionally
• Ability to work on a computer the majority of the day
• Potential limited exposure to hazardous chemicals
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

About this company
37 reviews
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...