Compliance Manager



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Compliance Manager

The Compliance Manager will provide leadership, direction and inspire a team of talented members. By being a strategic member, you will help create and maintain custom programs to facilitate MEDISCA operations, increase overall productivity and ensure customer satisfaction. You will be responsible for anticipating potential Regulatory issues & opportunities and proactively develop & implement solutions by applying risk-benefit assessment. This role reports directly to the Director of Regulatory and Legal Affairs; and serves as a key member of the MEDISCA management team.

The opportunity:

  • Ensure Compliance within All Facilities and markets (Canada, US, EU, Australia)
  • Keep updated with all State, Provincial and federal Regulations on Active Pharmaceuticals and finished products
  • Build relationships and act as the main contact with Regulatory Agencies
  • Manage Regulatory filings & review/approval process for products in portfolio to secure timely approvals
  • Create Regulatory Guides and train appropriate personnel
  • Ensure SOPs are compliant with applicable regulations through Change Request Approval
  • Responsible for reporting and follow ups on adverse reactions to regulatory agencies
  • Manage and delegate tasks on several projects
  • Plan and conduct trainings for internal employees
  • Support and ensure knowledge sharing between team members
  • Review and observe worldwide regulatory guidelines
  • Assess products under strict guidelines and keep proper documentation
  • Assess all new products and manufacturers for regulatory compliance
  • Responsible for coordinating and following up on recalls and other product issues
  • Act as a Regulatory Affairs Host for all audits
  • Managerug submissions with consultants
  • Develop and implement regulatory strategies to ensure compliance with current and upcoming changes to regulations
  • Manage and proactively assess any ongoing issues, develop a plan of action and lead their team in resolving the issue
  • Review and approve marketing material
  • Attend seminars, webinars and meetings hosted by Regulatory Bodies
  • Respond to daily request from internal departments and request from external sources
  • Back-up to the Director of Regulatory & Legal Affairs

TRAVEL: Up to two (2) weeks per year to attend conferences

Required Skills:
  • Excellent communication skills; fluent English, good French (oral & written)
  • Knowledge of FDA and Health Canada regulations is required
  • Ability to coach and influence team members in areas of expertise
  • Ensure knowledge sharing and mentoring of colleagues in Regulatory Affairs
  • Strong organizational skills and attention to details
  • Ability to demonstrate good judgment and decision making skills
  • Must be resourceful and possess good analytical skills
  • Knowledge in project management
  • Good command of Microsoft Office (Word, Excel, Outlook)
Required Experience:
  • University degree in a science-related discipline
  • Progressive experience in Regulatory Affairs and/or Quality (5 years)
  • 5+ years experience leading and developing high-performance teams

Why work for MEDISCA:

  • We strive to recruit the best talent
  • We are committed to developing excellence in all our employees
  • We offer excellent benefit package, a competitive salary as well as excellent career growth opportunities in a fast growing company

Be a part of our winning team and take advantage of the opportunity to excel in an exciting career that helps make a difference in the lives of millions of people through MEDISCA and the pharmacy compounding industry. Apply now for the Compliance Manager position.

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.


 

Company Overview


MEDISCA Pharmaceutique Inc is an FDA (Food and Drug Administration) registered supplier of fine chemicals, which include: - Active pharmaceutical ingredients (APIs) - Excipients in the form of bases, oils, colors, and flavors - Reusable and disposable devices for compounding pharmacists across the United States, Canada, Australia, and Europe. MEDISCA Pharmaceutique Inc is committed to bringing to the pharmacy compounding community the highest quality fine chemicals, compounding supplies, compounding solutions, and training.

MEDISCA Pharmaceutique Inc's trusted partner and educational arm, MEDISCA Pharmaceutique Inc NETWORK supports ACPE-Accredited pharmacy compounding training programs: Certificate Programs in Pharmacy, workshops, and symposiums. MEDISCA Pharmaceutique Inc NETWORK's Technical Support Services Department provides customized and on-line formulas, along with a customer service help line to answer compounding-related questions regarding compounding equipment, compounding scripts, and compounding medications.


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