Manager, Corporate Compliance

Apotex; Toronto; Presencial; CAD 97.000 - 161.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus programs

Comprehensive benefits

Pension plan

Learning and development opportunities

Descripción de la vacante

Apotex Inc. is seeking an experienced Regulatory Compliance professional to execute critical incident escalations and market action programs.

You will interface with regulators, liaise with stakeholders, and provide regulatory guidance to ensure overall quality and compliance across global operations. The role requires 8–10 years of GMP-regulated industry experience, strong English communication, and expertise with Health Canada/FDA regulations, SAP and TrackWise.

Formación

• GMP knowledge across Health Canada, FDA and global regulations.
• Strong written and spoken English.
• Organizational and interpersonal skills.
• Ability to work under pressure in an international matrix organization.
• Experience with regulatory notifications and recalls systems.
• Cross-functional leadership and problem solving.

Responsabilidades

• Develop and maintain relationships with external Regulatory Agencies and internal stakeholders to ensure timely notifications and resolutions of potential defects.
• Interact with regulators, health ministries, global affiliates and customers on compliance matters.
• Serve as a regulatory contact for queries from partners and affiliates.
• Evaluate regulatory trends and report risks to Apotex.
• Support Regulatory Systems & Compliance for notification and recall processes.
• Develop and implement SOPs and controls to sustain quality standards.
• Provide prep for inspections and audits by regulatory authorities and third parties.
• Represent Corporate Quality & Compliance during site inspections and with customers.
• Provide insights on regulatory requirements and changes in the regulatory environment.

Conocimientos

GMP knowledge

Regulatory affairs

English proficiency

Cross-functional

Problem solving

SAP

TrackWise

Excel

MS Office

Educación

B.Sc. in Chemistry/Biochemistry or related science

Herramientas

SAP

TrackWise

Excel

MS Office

Descripción del empleo

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Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

This position is responsible for executing critical incident escalations and market action programs. Interface with regulators and liaise with stakeholders across the business to support quality and compliance team. This position provides compliance oversight, support during regulatory inspection, review and develop regulatory authority communications globally and perform industry trend analysis, as required.

Job Responsibilities

• Develop and maintain effective relationships with external Regulatory Agencies and business partners as well as internal Apotex stakeholders in order to ensure timely notifications and resolutions to discovered potential pre and post distribution product defects.
• Responsible for interacting with regulators, ministries of health, global affiliates and customers on compliance related matters as required.
• Act as a compliance contact for regulatory queries and issues from partners and affiliates.
• Evaluate current regulatory trends and reporting on risks to Apotex.
• Support Associate Director, Corporate Systems & Compliance w.r.t. the Regulatory Notification system to ensure Health Agencies are notified within required time frames of potential defects for distributed products, and support ad hoc communication with Health Authorities.
• Support Associate Director, Corporate Systems & Compliance w.r.t. the Recall system to ensure timely and complete product recalls are effectively performed.
• Develop and implement appropriate business processes and controls including SOPs, in order to maintain effective quality standards.
• Provide preparatory support for post-market inspections and audits by Regulatory Authorities as well as third parties as required.
• Represent Corporate Quality & Compliance during site and functional area inspections by Regulatory Agencies and external customers.
• Provide recommendations to senior management that have direct impact on commercial products.
• Provide information/insight on regulatory requirements and stay abreast of changes in regulatory environment/trends.
• Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance.

Include the following for all Individual Contributors (those who are not People Leaders)

• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
• B.Sc. in Chemistry, Biochemistry or a related science
• Knowledge, Skills and Abilities
  • Demonstrated & thorough knowledge of the GMPs relative to Health Canada, FDA and other global pharmaceutical regulations.
  • Clear and concise written and verbal English communication
  • Strong organizational, interpersonal and communication skills.
  • Ability to work under pressure and effectively in an international and multicultural matrix organization.
  • Flexibility in response to a changing and evolving environment, deadline oriented.
  • Exhibited business acumen in understanding cross-functional processes, requirements, and relevant information flows, and translating gaps into solutions.
  • Demonstrated strategic, process-driven, analytical, and critical thinking.
  • Proven experiences in holding people accountable, developing cross-functional teams, and facilitating decision-making processes.
  • Knowledge of SAP, TrackWise, excel, word, other Microsoft office programs
• Experience
• Minimum 8-10 years of experience in the GMP Regulated industry.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

The hiring range for this position is $96,551.00- $160,918.00 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.
We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.
The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.