Director of CMC-Regulatory Strategy

Job Description

The Director of CMC Regulatory Strategy will determine the required Global CMC-Regulatory activities to support this commercial product portfolio and lead the CMC-Regulatory Strategy team.

They will have overall responsibility and leadership for the strategy and execution of CMC-Regulatory filings including authoring, coordination, review and approval for the assigned product portfolio, working closely with manufacturing sites and partner companies to ensure alignment.

In this key position, the Director of CMC-Regulatory Strategy will ensure the operation of an effective and strategic CMC-Regulatory team so that the quality of the Company's products is enhanced or maintained, the patients' interests are protected and the company's objectives are met.

Responsibilities

• Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy with all stakeholders.
• Takes accountability/decision making for all Global CMC-Regulatory files in the assigned product portfolio including medical device Technical files where applicable
• Ensures all CMC-Regulatory dossiers data remain relevant, compliant, current and aligned with global regulatory processes and practices.
• Develops and then maintains efficient, compliant and robust systems, procedures and processes so that everyone involved in the CMC dossier process is clear as to their role, providing the right data in the right format, per schedule and in compliance with requirements.
• Monitors the development of existing pharmaceutical regulations and communicates them to all appropriate functions.
• Attends the required global scientific advice meetings to ensure successful strategic outcomes for their assigned CMC-Reg Strategy product portfolio
• Assesses CMC-Regulatory impact of all changes relating to the allocated product portfolio, propose and communicate prioritisation of changes to reflect company/department objectives.
• Contributes to the Global CMC-Regulatory Strategy risk register and works with senior management to prioritise resolutions
• Monitors and reports on CMC-Regulatory activities and process performance for the allocated product portfolio; identify areas for improvement, implement and monitor subsequent actions.
• Ensure the team delivers timely submission-ready CMC dossiers for the allocated product portfolio. Coordinate all related CMC-Regulatory activities including responses to questions from Regulatory agencies, variations and new Marketing Authorisations
• In liaison with Local Quality, Global Quality, participates and supports Regulatory Authority site Inspections taking responsibility for inspection readiness for all CMC-Regulatory activities in the scope of the inspection for a product in their assigned product portfolio
• Determine activities needed and prioritise plans for team, based on compliance and supply demands
• Present CMC-Regulatory Strategic plans to business units and senior management
• Ensure optimised communication with vendors and partners involved in the CMC-Regulatory process. Resolve any issues with internal partners and external vendors to ensure goals are met.
• Ensure the agile execution of the CMC-Regulatory process and related activities.
• Ensure the Qualified Persons and/or Quality Release sites are provided with accurate and up-to-date CMC-Regulatory information to ensure proper and fully compliant release for each market
• Line Management of direct reports based at a minimum of two different company site/entity locations
• Lead an adaptable, responsive and efficient workload levelling system in the CMC-Reg team
• Coach and motivate the team to ensure high team performance
• Develop and maintain new starter and training plans ensuring all associated procedures are maintained as current and evolve with changing regulations
• To enhance the company's visibility within the external environment, takes opportunities to present at symposia/external training events and be an expert within a dedicated regulatory area
• Keeps abreast of regulatory changes

Requirements:

• Masters or BSc. in Pharmaceutical /Biological/Chemical Science or relevant scientific discipline
• Over 10 years' work experience in multinational Life Science companies with at least 8 years relevant CMC Regulatory experience in the lifecycle management of primarily biological products is essential.

• Two years Line Management of remote teams up to Manager level
• Experience should include clinical development (IND/IMPD), registration and post-approval activities in US, EU and major Intercontinental markets e.g., China, Japan. Experience with medical devices is a plus.
• Demonstrated experience in the development and implementation of global CMC-Regulatory strategies for major regulatory submissions.

• Proven significant experience in the regulatory CMC biologics, small molecules and High Potency field. Particularly, sound technical knowledge of the manufacture of pharmaceuticals to include biological and chemical drug substances and drug products and the inter-relationships of development, manufacturing, quality, supply chain functions.
• Proven experience in managing product site transfers and associated comparability plans.
• In-depth knowledge of US & EU regulatory requirements pertaining to the registration and lifecycle management of pharmaceutical biological drug substances and drug products.
• Proven CMC-Regulatory lifecycle management experience with other global markets, such as Japan, China, Canada and Intercontinental markets is required.
• Experience with leading the CMC-Regulatory aspects of scientific advice meetings.
• Strong regulatory writing experience with the ability to summarise and communicate complex topics concisely to senior management.
• Excellent critical thinking, written, verbal and interpersonal communication skills.
• Analytical mindset and excellent attention to detail
• Ability to handle multiple priorities and complex projects in a fast-paced environment.
• Experience working with contract manufacturers and influencing strategies with external parties.
• Line management experience is essential.
• Experience building new teams in changing environments is desirable.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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