POSITION DESCRIPTION

Role / Position Title - Regulatory Affairs Manager - CANADA

Country - Canada

Region / City - Concord, Ontario

FLSA (Exempt/Non-Exempt) - Exempt

POSITION SUMMARY

Reporting to the Associate Director, Regulatory Affairs, this position is responsible for managing functional activities to ensure that the company’s goals and objectives are met. This position also manages compliance within the department and ensures that global, regional, and local processes are followed. The ideal candidate understands the regulatory landscape, including its impact across business units, and is expected to communicate any changes to the regulatory environment to all relevant stakeholders.

OVERALL JOB RESPONSIBILITIES

Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Responsible for submission content (compilation/writing, review, edit) for NDSs, S/NDSs, ANDSs, S/ANDSs, NCs, Cross-license applications, DEL applications, Drug Notification Forms (DIN), Level III & IV Changes and CPID Update for prescription, OTC drug products, NHPs.
• Responsible for submission content (compilation/writing, and/or, review, and/or, edit) of responses to Health Canada deficiency letters (ie. Clarification Requests, Notice of Deficiency (NOD), Notice of Non-Compliance (NON), etc.).
• Prepare product labelling (including Product Monographs) and coordinate French translations.
• Review of published submissions in eCTD format to ensure compliance with Health Canada’s requirements prior to filing via the electronic gateway.
• Responsible for provincial submissions and support with drug product listing in coordination with marketing.
• Assist the Associate Director of Regulatory Affairs on assigned projects/duties.
• Maintains approved products in compliance with all Health Canada regulations, including DEL.
• Review change controls and provide regulatory impact assessment, including execution of any filing requirements.
• Monitor Health Canada safety alerts for updates to CRP PMs, and file Post-NOC NCs, as applicable.
• Provide support for new regulatory policies, strategies, processes, SOPs, etc., where applicable.
• Ensure compliance with global and regional SOPs.
• Provide current status of regulatory guidances, familiar with latest regulations, awareness of competitive performance.
• Maintain awareness and communicate with team members regarding changing regulatory environment and requirements.
• Participate in local and global Regulatory Affairs initiatives.
• Provide regulatory guidance and support to R&D, Clinical, PV, and QA, as well as in the development of new company products.
• Coordinates audit/inspection preparations and responses
• International and domestic travel.

KNOWLEDGE, SKILLS AND ABILITIES

Education:

• Minimum Bachelor of Science in Life Sciences; Master’s Degree preferred.
• Graduate Certificate in Pharmaceutical Regulatory Affairs is an asset.

Experience:

• 6-12 years of work experience in Regulatory Affairs.
• Experience liaising with Health Canada. A minimum of four years of experience filing regulatory submissions with Health Canada is an asset.
• Experience in Research & Development, Quality Control, Quality Assurance, Production, Clinical trials, Toxicology in Pharmaceutical Industry is an asset.

Skills:

• Demonstrates a thorough knowledge and understanding of all Health Canada regulations, guidances, and policies (Food and Drugs Act and Regulations), Good Manufacturing Practices, Drug Establishment Licensing.
• Experience with submissions for different dosage forms is an asset (e.g. solid oral dosage forms, injectable, semi-solids, inhalation products, etc.)
• Strong technical strength and the ability to think outside of the box/creative approaches without risking submission quality.
• Ability to foster strong working relationships with key stakeholders (internally and externally) and representatives from Health Canada.
• Strong multi-tasking, organizational and interpersonal skills.
• Balances a sense of urgency of time pressures with adherence to all regulatory requirements.
• Demonstrates advanced oral and written communication skills including editing of documents prepared by others.
• Proficient in computer applications (Microsoft Office Word, Excel, PowerPoint, etc.).
• Well understanding of cross-functional interactions needed by RA to compile comprehensive submission is a must.
• French language proficiency is an asset but not a requirement.
• Ability to work independently with minimal supervision.

Physical demands and abilities

• The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.
• The noise level in the work environment is typical of that of an office
• Incumbent may encounter frequent interruptions throughout the work day.
• The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds

ABOUT GLENMARK

Glenmark Pharmaceuticals is a global pharmaceutical company with a remarkable track record of achievement and improving patients’ lives with access to affordable medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.

Glenmark has the stability, resources and talent to work on solving serious medical problems, all while doing the right thing for patients, people and communities.

Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.

BENEFIT HIGHLIGHTS

• Paid time off
• 401k plus company match
• Company paid health benefits
• Dental
• Vision
• Onsite access to company gym
• Corporate Discount Program
• Paid Employee Referral Program
• EAP – Employee Assistance Program
• Accident Insurance
• Critical Illness Insurance
• Commuter Accounts
• Short-Term Disability
• Life and AD & D Insurance
• Whole Life Insurance
• Pet Insurance and so much more!

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.