Regulatory Affairs Manager

Job Summary

Responsible for leading Regulatory Affairs activities for  LATAM region. This is to be accomplished by working collaboratively with both internal and external stakeholders to plan, prioritize, strategize and execute all activities associated with regulatory filings and any other regulatory activities to get a product submitted, approved, launched and to maintain supply continuity in all LATAM markets as assigned.

Job Responsibilities

• Responsible for regulatory activities to support new product submissions, approvals, launches as well as activities required to maintain commercial supply of approved products for assigned markets in the LATAM region.
• Will have full oversight and accountability for NPD and PLCM activities for the markets assigned
• Develops and maintains effective relationships with external vendors, suppliers, business partners (such as affiliates and customers) and internal stakeholders in order to ensure business needs are met.
• Implements business objectives, R&D initiatives and regulatory strategy focusing on process improvements to maintain products in LATAM region.
• Responsible for planning workload / projects (i.e. submissions, training plans, deficiency responses, audits, alunches, variation filings, renewals etc.) and managing processes to ensure objectives of department and submission and approval timelines are met. Prioritizes projects in support of commercial business needs.
• Responsible for ensuring timely approval of the regulatory submissions with high quality technical submissions and monitoring Agency reviews.
• 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 and provides impact analysis in relevant forums associated with new submissions, launches as well as to support ongoing commercial supply of product. Supports Corporate Business processes (change control, compendia, labelling & artwork) by developing regulatory solutions and implements action plans for identified product issues to mitigate risks, informing and escalating as required.
• Stays abreast of changes in regulatory environment / trends and proactively implements or updates existing processes to ensure compliance while maintaining supply of products as per business need.
• Provide guidance and participate as required in recruitment, training, developing and effective management of ongoing performance of regulatory individuals in the team.
• Manages compendia and compliance activities (including but not limited to audit preparation, regulatory information management system updates and regulatory info supporting quality management systems) for regulatory affairs teams and is responsible to ensure that consistent and compliant practices are followed for all regulatory activities.
• Participate and lead 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.
• Utilize open, honest, two way communication to build trust-based relationships with cross-functional employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and demonstrates our core Values – Individual Accountability, Rigour & Discipline, Continuous Improvement.
• Ensure adherence with all compliance programs and company policies and procedures.
• All other 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 detailed knowledge of the technical, compliance, and regulatory requirements for the LATAM region
  • Good Leadership skills and ability to work with internal and external stakeholders across the globe through different time zones
  • Excellent communication, presentation and interpersonal skills with English language as a strong skill
  • Excellent conflict management skills
  • Demonstrated experience in supervising, influencing and coordinating the complex activities and interaction of staff, including non-direct reports
  • Strong organisational skills; ability to work independently and manage priorities
  • Demonstrated knowledge of the generic new product development process
  • Excellent understanding of Project Management principles and practice in a complex environment
  • Knowledge of Canadian, US, EU and other International markets regulatory guidelines will be an asset
  • Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS-Excel
• Experience
  • 5- 8 years progressive experience in the regulatory affairs pharmaceutical industry
  • 2 years experience in Management role
  • Advance English