Manager Regulatory Affairs(PLCM)

Job Summary

Responsible for leading Regulatory Affairs individuals accountable for management of life cycle changes including change assessments and submissions all the way to approvals of PLCM (Product Life Cycle Management) projects to support regulatory compliance continued supply of Apotex products. Also responsible for Global Regulatory practices to manage regulatory information in various databases and ensure consistent practices and compliance is maintained at Global Apotex sites. This is to be accomplished by planning and managing the activities of the group. Strong linkages need to be established with R&D Quality Operations and the Regulatory Market Affiliates/customers (Canada US EU AUS and NZ) and Regulatory partners at Global Apotex sites. Responsible for coaching team members via sharing of technical knowledge/expertise.

Job Responsibilities

• Responsible for planning workload / projects (i.e. change assessments submissions training plans deficiency responses audits etc.) and managing processes to ensure objectives of department and submission and approval timelines are met. Prioritizes projects in support of commercial business needs.
• Reviews and ensures timely submission of post-launch variations and completes any other activities as assigned in a timely manner to ensure supply continuity through smart regulatory strategies and quality submissions.
• Handling of deficiencies received from Apotex Affiliates and/or customer and health regulatory agencies for post-launch variations.
• Responsible for ensuring timely approval of the PLCM projects with high quality technical submissions and monitoring Agency reviews with the Regulatory Market Affiliate.
• Standardizing processes guiding reviews ensuring quality and compliance of submissions with technical expertise.
• Represents Regulatory Affairs in cross-functional team meetings and provides impact analysis in relevant forums associated with PLCM to support ongoing commercial supply of product. Supports Corporate Business processes (change control compendia etc.).
• Develops & proposes regulatory solutions and escalates action plans for identified product issues to mitigate risks as required. Challenges the status quo.
• Develops and maintains effective relationships with external vendors suppliers business partners and internal stakeholders in order to ensure business needs are met.
• Implements business objectives R&D initiatives and regulatory strategy focusing on process improvements.
• Regular interactions with stakeholders to discuss on expectations deliverables/priorities and provides solutions to regulatory issues and/or problems.
• Stays abreast of changes in regulatory environment / trends and escalates appropriately to ensure that regulatory practices at global Apotex sites are updated as needed.
• Provides guidance and participates as required in recruitment training developing and effective management of ongoing performance of regulatory individuals.
• Manages compliance activities (including but not limited to audit preparation regulatory information management systems and regulatory info supporting quality management systems) for global regulatory affairs teams and is responsible to ensure that consistent and compliant practices are followed at all Apotex sites.
• Contributes and encourages team members towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect.
• Works as a member of a team to achieve all outcomes.
• Completion of all the assigned trainings in timely manner.
• Supervises work of direct reports determining training requirements performing regular performance reviews and executing development plans in co-ordination with Reporting Manager.
• Leads performance conversations ensuring progress support and clear expectations fostering a high-performance safe work environment.
• Utilizes open honest two-way communication to build trust-based relationships with employees business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Creates a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Collaboration Courage Perseverance and Passion.
• Attract hire and onboard talent through networking ensuring a consistent value-driven experience for new employees.
• Ensures adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

Job Requirements

• Education
  • A Graduate/ Post graduate degree in Chemistry Biology Pharmacy Health Sciences or similar.
    
    
• Knowledge Skills and Abilities
  • Must possess detailed knowledge of the technical quality compliance and global regulatory requirements.
  • Excellent communication presentation and interpersonal skills.
  • Excellent Leadership negotiation problem-solving and conflict management skills.
  • Demonstrated experience in supervising influencing and coordinating the complex activities and interaction of staff including direct and non-direct reports.
  • Strong organisational skills; ability to work independently as well as in dynamic team environment.
  • Strong ability to lead a team of professionals.
  • Demonstrated knowledge of the generic new product development and post approval management process.
  • Excellent understanding of Project Management principles and practice in a complex environment.
  • Excellent oral/written communication in English.
  • Knowledge of recent updated Guidances of Health agencies is a must.
  • Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word MS-Excel and MS-Project (or other PM software).
    
    
• Experience
  • 15 years progressive experience pharmaceutical industry.
  • 10 years regulatory filing experience with exposure to PLCM & compliance activities for Finished Dosage forms.