Manager GMP Regulatory Compliance

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
How will you make an impact?
Provide direction and management for regulatory compliance to ensure that the Toronto site remains in a state of regulatory control. Support various regulatory compliance and submission activities as requested by Clients and Health Authorities. Verify compliance with the registration dossier of the drug product, the implementation in the company documentation of the contents of the registration dossier, the implementation of the external inputs in terms of legislation (directives, regulations, ICH, WHO, Health Canada, FDA, EMA, PMDA, GMP) and corporate policies. In addition, the collection and issuance of necessary documents to support site/paper regulatory inspections and regulatory submissions for various international Health Authorities as requested by clients.
What will you do:
Regulatory Compliance and Submissions

• Ensure and govern regulatory compliance activities with other functional departments by means of audits to meet company standards and by verifying and ensuring the implementation of procedures by GMP requirements and regulations.
• Facilitate, guide, and fulfill regulatory-related requests from Clients and Health Authorities to ensure adherence that all GMP documentation necessary to support regulatory inspections, product drug submission dossiers, product launches, the drafting and/or review of any required site licensing, registration certificates, applications, and renewals.
• Govern site regulatory awareness for each regulatory Health Authority (domestic and international).
• Interact with Health Canada related to Drug Establishment License, Medical Device License, GMP Certificates, API Importation, and management of Table A to meet Health Canada requirements.
• Manage and support activities for FDA Drug Product Listing, USDA, GDUFA, PDUFA, US State Licensing and foreign site accreditations.
• Foster cooperation and lead discussions to resolve issues with other functional areas (as required).
  

Auditing function

• Registered Notary Public for Toronto and Whitby sites (Whitby site only when required).
• Select, develop, and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures.
• Provides updates to the site for changes in regulatory space and ensures that internal procedures are updated to reflect these changes.
• Act as Subject Matter Expert during regulatory and client audits
  

How will you get here:
Education:
Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, or other related field.
Experience:
Minimum 8 years of compliance or regulatory experience within the pharmaceutical industry.
Experience In CDMO Environment Is Preferred.
Previous supervisory and/or leadership experience
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Exceptional Good Manufacturing Practices and ARFs /HPBI/FDA (Food and Drug Administration) compliance knowledge. Possess a highly developed quality, regulatory and production mentality with an appreciation for client service and the contract manufacturing industry. Project Management capabilities. Superior interpersonal and communication skills (both oral and written), leadership, motivation, and organizational qualities. Proven leadership and problem-solving abilities. Ability to prioritize multiple project deliverables. Organized and detail oriented. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
Physical Requirements:
Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com