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Regulatory and Quality Manager
Verona, WI
Job Description
POSITION OVERVIEW
The primary role of the Regulatory and Quality Manager position is to provide regulatory guidance for the company to ensure compliance with US and International guidances. The Regulatory and Quality Manager will oversee the development, preparation, and submission of regulatory documentation, including but not limited to, Drug Master File and Annual Drug Product Review. The Regulatory and Quality Manager will keep abreast of current and future US and International guidances, provide support to the Supply Chain Qualification program, and assist with Quality technical investigations and deviations.
ESSENTIAL JOB FUNCTIONS
- Supervise the Regulatory Specialist activities.
- Responsible for Drug Master File and Annual Drug Product Reviews.
- Oversee development, preparation and electronic submission of regulatory documentation.
- Work with client representatives to support their regulatory needs, including the development, preparation, and review of regulatory submissions (letters of authorization, INDs, etc.).
- Assist in the establishment of current and future regulatory requirements for our business activities and functions which are highly interdependent with other departments including Sales and Manufacturing.
- Support Quality technical investigations and deviations.
- Support Supply Chain qualification and audit activities.
- Provide knowledge of current and future regulations with regard to raw materials, storage, packaging, labeling, and other related areas of compliance.
- Develop, coordinate, and implement regulatory strategies for new and existing products that require governmental approval.
- Assist in preparation for and participate in FDA (and other relevant regulatory authorities) face-to-face and teleconference meetings.
- Monitor and manage the submission of international regulatory export documentation for accuracy, completeness, and timeliness.
- Perform literature searches and regulatory review of publications to assure up-to-date compliance with US and international regulations, and communicate findings to appropriate internal customers.
- Identify areas of process improvement and propose new solutions designed to increase value and improve performance within Regulatory and Quality Systems.
- Resolves complex regulatory challenges by using creative and flexible thinking.
- Author applicable Quality, Regulatory and Supply Chain SOPs.
- Author required regulatory statements.
- Maintain compliance with all company policies, plans, and procedures, including safety, security, and regulatory.
- Other duties as assigned.
EDUCATION/SKILLS/KNOWLEDGE REQUIRED
- Bachelor’s Degree in scientific discipline or equivalent required; advanced degree desirable.
- This position requires a minimum of 7+ year’s regulatory experience in the pharmaceutical, contract manufacturing, or related industry.
- Significant knowledge of the pharmaceutical, contract manufacturing, and/or medical device industry, its products, packaging, and manufacturing practices.
- Extensive knowledge of US and International regulations including: The Fair Packing and Labeling Action (FPLA), Good Manufacturing Practices (GMP), Federal EPA and US state environmental regulations, as well as EU and Canada regulations.
- Environmental, Health, and Safety Knowledge, a plus.
- Ability to build and maintain effective relationships with both internal and external customers in an effort to facilitate effective communication of business needs.
- Proficient in Microsoft Word, Excel, SharePoint, and Acrobat Professional.
- Expertise in identifying and solving complex regulatory and/or legal issues.
- Experience in planning, coordinating, and executing multiple projects simultaneously.
- Outstanding written, verbal, and interpersonal communication skills required.
- Strong attention to detail.
Job Summary
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40+
Work Hours (i.e. shift)
8AM - 4:30PM
Salary and Benefits
Based On Experience
Required Education
Bachelor's Degree
Required Experience
7+ years
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