The ODAN Advantage:

• Growing specialty pharmaceutical company
• Group Insurance plan, with Dental and LTD Benefits
• Onsite free parking
• Friendly work environment

We are looking for candidates who are engaged and want to make a difference!

POSITION SUMMARY - DIRECTOR REGULATORY AFFAIRS

This person will be responsible for the formation of the global regulatory strategy involving the direction and management of resources and activities in the development and implementation of regulatory strategies leading to the rapid submission and approval of dossiers meeting the requirements of Health Canada and FDA and the needs of the company.

QUALIFICATIONS REQUIRED:

• Must have B. Sc. Degree in Pharmacology, Biochemistry and/or relevant disciplines or equivalent experience in industry (i.e Life Sciences)
• Minimum ten (10) years of experience in the Regulatory affairs of a Pharmaceutical or related field, with at least five (5) years in a senior position.
• Knowledge of the Canadian and American Regulatory Guidelines and GMPs
• Ability to assimilate complex technical concepts and summarize appropriately for use with regulatory bodies
• Excellent planning, organizational and communication skills, combined with a confident ability to work independently with minimum supervision and under stringent timelines and minimal resources
• Excellent knowledge with preparation of e-CTD documents
• A strong record of good decision making/judgment
• Ability to manage and work on multiple projects at one
• Excellent verbal and written communication skills
• Master Microsoft Office
• Bilingualism, French and English (oral and written)

ODAN - DESCRIPTION DE L’ENTREPRISE :

Fondée en 1974 à Montréal, Canada, Les Laboratoires Odan est une entreprise pharmaceutique spécialisée 100 % Canadienne. Infrastructures intégrées pour la R&D, la fabrication, la distribution et le marketing de nos produits. Notre vaste gamme de produits innovateurs inclut des médicaments gastroentérologiques, dermatologiques, sans ordonnance, de spécialité et génériques. Les produits Odan sont distribués aux pharmacies de détail, hôpitaux, institutions gouvernementales et grossistes pharmaceutiques. Odan exporte ses produits à travers le monde. Odan est continuellement à la recherche et au développement de nouvelles molécules pharmaceutiques et ajoute régulièrement à son portfolio.

• You will be responsible for the preparation, filing and maintenance of filings for CTAs/INDs ANDS, NDS, DINAs, Labelling standards, etc., according to existing guidelines and corporate objectives.
• You will be responsible for the Company’s Pharmacovigilence Program for all post-marketed drug products
• You will assist in replying to MedInfo queries on entire company portfolio
• As the most senior person in regulatory affairs, your role will also include representing company on all Regulatory matters with the various Regulatory Inspectorates including responding to Clarifaxes, Notice of Deficiency (NOD) and Notice of Non-Compliance (NON)
• You will be responsible in elucidating the Regulatory path for all new in-licensing and in house development programs
• You will work in conjunction with other disciplines during due diligence exercises in identifying gaps for all in-licensing opportunities
• You will participate in portfolio product selections
• You will be responsible for maintaining company’s GMP, Controlled Substance and Device licenses for all prescription and natural health products
• You will review and approve artwork changes to all commercial products where applicable
• You will oversee the graphics department to ensure compliance to Regulatory requirements when it comes to claims, composition and structure of all printed components and ensure that our branding strategy is consistently applied
• You will provide guidance and coaching to the Regulatory Affairs Associates on all Regulatory matters