Project Manager, New Product Development (Regulatory Affairs)

Project Manager, New Product Development (Regulatory Affairs)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.
Responsible for leading New Product Development (NPD) submission activities, including but not limited to, due diligence activities for new product opportunities, new product development submissions, and associated activities such as deficiency responses. Strong linkages need to be established with internal colleagues and development partners. Leads development of strategies and operations for projects under the NPD portfolio within GRA.
Job Responsibilities
Develops regulatory project strategy with appropriate risk mitigation strategies incorporated
Ability to recover projects that are at risk
Prepares/leads regulatory submissions according to current requirements, and taking into account current deficiency trends
Assesses potential deficiencies and works with internal/external team members to address prior to submission, or if not possible, in advance of deficiency receipt
Leads development of optimal deficiency response strategies with internal and external stakeholders;
works with stakeholdersto review/finalize responses that fully/optimally address the regulator’s deficiency questions;
leads discussion with stakeholders to finalize deficiency responses by the target response date
Conducts thorough due diligence of opportunities brought forward by the Business Development team, and identifies all regulatory risks associated with the potential opportunity;
if not provided with initial data package from the partner, requests for key elements required to conduct the thorough assessment, based on status of the development/submission for the opportunity.
Supports seamless product launch through timely review of change proposals, change controls, provision of documentation, and other activities as required.
Executes change control assessments, and any subsequent activities required as a result of the assessment (regulatory submissions, database updates)
Trains and provides guidance to peers as required
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, biology, pharmaceutical, engineering, health sciences or a related field required.
Knowledge, Skills and Abilities
Must possess strong knowledge of regulatory requirements associated with new drug submissions, and have familiarity with technical/quality / clinical /non clinical aspects associated with these products
Excellent communication, presentation and interpersonal skills
Excellent conflict management skills
Strong organisational skills;
ability to work independently and manage priorities
Strong Leadership skills
Demonstrated knowledge of the new product development process
Knowledge of Canadian and US regulatory guidelines a must
Knowledge of and experience with the MS-Office suite of products
Experience
8+ years progressive experience the pharmaceutical regulatory affairs
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 $ 95,594.40- $ 133,832.16 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.
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