Project Manager, New Product Development (Regulatory Affairs)

Job Summary

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 stakeholders to 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 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 generic 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