Senior Manager, Regulatory Affairs
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Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
About Apotex Inc.
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.
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Job Summary
To coordinate within team and third-party manufacturing/development sites to organize co-development projects which includes new submissions deficiency responses and Product Life Cycle Management (PLCM) of approved products to various regions.
Job Responsibilities
- To coordinate within team and third-party manufacturing/development sites for Co-development projects.
- Author/Review of dossiers deficiency responses and supplements/variations to various Regulatory Authorities like USFDA Health Canada TGA and Medsafe etc.
- Responsible for coordinating internally and externally for New Product Launch of Co-development projects.
- Responsible for quality eCTD/CTD submissions to various Regulatory Authorities within the stipulated and agreed time frame.
- To assess and provide regulatory strategy for the changes proposed by the different third-party manufacturers for co-development products.
- 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.
Responsabilités inhérentes à lemploi
Job Requirements
- Education
- Skills and Abilities
- Sound understanding regulatory affairs submissions.
- Expertise in product life cycle management.
- People management skills.
- Ability to learn and adapt quickly.
- Ability to manage full workload across multiple projects.
- Excellent verbal and written communication skills
- Experience
- 8 to 10 years of experience in Regulatory Affairs activities which must include 3 to 4 years of experience in team/people management.
- Skills and Abilities
Exigences liées au poste
At Apotex we are committed to fostering a welcoming and accessible 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.
Required Experience:
Senior Manager
About Company
Apotex is the largest Canadian-owned pharmaceutical company providing patients around the globe with quality, affordable medicines. We are an innovative global research and technology leader in generic pharmaceuticals that serves customers and partners in the U.S. market, as well as 1 ... View more
