Manager, API & RM Changes - PLCM

Job Summary

Responsible to provide regulatory strategy, review, and direction to the business regarding the global regulatory maintenance of currently marketed products (PLCM – Product Life-Cycle Management) specifically for post-approval changes driven by active pharmaceutical ingredients (API) suppliers, raw material suppliers and for new source qualification (NSQ) program. This is to be accomplished by planning and directing the activities within the Regulatory Affairs department in conjunction with all of R&D, Quality and Operations, as well as the Regulatory Market Affiliates/Customers in all the regions.

Job Responsibilities

• Accountable to develop and communicate the RA strategy to support post-approval submissions for API changes, raw material changes for all markets. Provides support to various corporate project teams, manufacturing sites and the regulatory teams across global sites, in the development of regulatory strategies for all markets for change management activities and compliance of sites.
• Supports the manufacturing sites on any compliance activities including but not limited to audits and audit preparation, responding to queries from the Health Agencies etc.
• Accountable to provide strategic/review inputs during pre-assessments, change control assessments & submission compilation stage for API changes, raw material changes, supplier driven changes (SDC) and for new source qualification (NSQ) program.
• Accountable to monitor and report on the progress/status of assigned submissions/projects, variations, and planned changes to the Reporting Manager.
• Act as the primary contact with the affiliates, customers, and regulatory agencies (as applicable) and requests meetings with the regulatory agencies (as needed), working in conjunction with the regulatory market affiliates/customers. Responsible, where necessary, to negotiate with the Agency on specific project issues.
• Sets and measures departmental objectives in support of Regulatory Affairs goals with respect to submissions and approvals for global markets.
• Represents Regulatory Affairs and provides impact analysis in relevant forums associated with PLCM to support ongoing commercial supply of product for all markets.
• Coach and provide direction to the RA, R&D, QA, and Commercial teams where applicable, to ensure that all facets of product life-cycle management are conducted in accordance with regulatory requirements and to ensure that the submissions are prepared in an accurate manner and of high quality to be able to achieve our primary objectives of one cycle review and supply continuity.
• Leads key RA initiatives and business objectives and ensures implementation.
• Responsible for creating and promoting an environment of teamwork and empowerment. Ensures the development of the required competencies of RA team for their roles and future progression in alignment with business objectives and goals.
• Keeps abreast of changes in regulatory trends in various regions, interprets the impact of the change, and works with senior RA management and Regulatory Market Affiliates regarding implementation and communication of the change.
• 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 employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create 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.
• Utilize your 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.
• Ensure 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, business discipline or similar. PMP an asset.

• 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: Core labelling Regulatory Affairs
  • At least 15 years’ progressive experience pharmaceutical industry.
  • 10+ years’ regulatory filing experience with exposure to PLCM & compliance activities for API, Raw Materials and Finished Dosage forms.