Manager - PLCM (Regulatory Affairs)

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 (Caribbean, EMEA, GCC, LATAM, APAC and any other international markets as assigned) 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.) for international / rest of world markets and managing processes to ensure objectives of department and submission and approval timelines are met. Prioritizes projects in support of commercial business needs.
• Ensures supply continuity via timely post-launch variation submissions and strategic regulatory execution for international markets.
• Handling of deficiencies received from Apotex Affiliates and/or customer and international health regulatory agencies for post-launch variations.
• Ensures timely PLCM project approvals through quality submissions and monitors agency reviews with affiliates.
• Develops departmental standards and operating policies and procedures. Provides technical guidance in the review and evaluation of submissions to ensure overall quality and compliance of work.
• 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 escalate 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 provide solutions to regulatory issues and/or problems.
• Monitors regulatory changes, communicates trends, and updates global Apotex practices for compliance.
• 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, assesses training needs, conducts performance reviews, and implements development plans.
• Participates and leads performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Fosters trust through open communication, builds relationships, and pursues leadership development via feedback.
• Cultivates a trust-based culture, enabling employee growth aligned with core values.
• Utilizes networks to attract and hire talent in a comprehensive, differentiated, and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• 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 Guidance’s 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.