Director, Regulatory Affairs

Position: Director, Regulatory Affairs (Contract)
Sun Pharmaceuticals Industries Inc. is the fifth largest generic pharmaceutical company in the world, and is rapidly building a branded product presence globally and specifically in Canada. Sun Pharma Canada Inc. has a team of 70 plus employees and a portfolio of 5 commercial products in the branded business and a pipeline of molecules in development. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately help patients.

At Sun Pharma Canada Inc. we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values:

Humility. Integrity. Passion. Innovation.

Job purpose

Develop and execute the regulatory strategy for SUN Innovative Medicines (IM) in-line and pipeline portfolios in Canada.

Effectively represent GRA at national and international level across levels (from CEO to junior staff)

Duties and responsibilities

Accountable/responsible for developing and implementing the overall Canadian drug (drug-drug or drug-device) regulatory strategy for SUN IM assets, including functioning as the regional (Canada) regulatory agent, coordinating all Health Canada regulatory agency meetings, overseeing and/or authoring regulatory documents, and ensuring all regulatory commitments are completed and executed on time and as per regulations

Managing a high performing local team of internal and external (contractor) talent

Staying abreast of relevant regulatory guidances and requirements

Providing regulatory infrastructure, operations, and program management support

Knowledge,

Skills and Abilities

Thorough understanding of ICH and Canadian requirements and regulations

Regulatory document submissions authoring experience (CTAs, IMPD, NDS, briefing books)

Regulatory agency direct interaction experience

Must have functioned as regulatory agent to Health Canada

Problem solver

Strong written and oral communication skills

Ability to operate in a dynamic and rapidly changing environment

Worked in a multi-cultural, multi-national work environment

Additional responsibility (Only applicable to customer facing roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

Masters degree in a scientific and/or legal discipline (e.g., medicine, chemistry, biology)

Preferred:
Ph.D/Pharm

D/MD/DPhil in a scientific and/or legal discipline

Minimum 10 years of national (Canada) drug regulatory affairs experience, with at least 5 years in a senior (managerial) position

Significant ( 10 years) of experience managing a portfolio of late- and commercial-stage and with multi-modalities (e.g., biologics, small molecule) is required

Working conditions

General office conditions.

Travel up to 15%

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $157,500 to $192,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. Employees are eligible to participate in Company employee benefit programs which include medical, dental coverage and the employee assistance program. Contract employees also receive vacation pay and paid sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a…