Manager CMC Regulatory Strategy

WHAT - Summary & Purpose Of The Position

Prepare the CMC regulatory strategy activities for the assigned projects throughout the different phases of development from early clinical trials to initial marketing applications, geo-graphical expansion, and life cycle management as assigned by CMC regulatory senior management including leading the preparation of the CMC submission dossiers.

To manage the CMC Regulatory relationship for their assigned product(s)/projects with Ipsen’s manufacturing sites and/or Ipsen’s External Manufacturing Organisation (EMO), Global Regulatory, CMOs and Alliance partner companies to ensure alignment of strategy.

CMC Regulatory Strategy

WHAT - Main Responsibilities & Technical Competencies

• Lead the development of CMC regulatory strategy (overall CMC regulatory roadmaps) for the assigned projects (new products in development and/ or commercial product(s) for both lifecycle management and geographical expansion through new MAA registrations) ensuring the CMC reg risks are identified, assessed, shared and managed as appropriate; and verifying the CMC regulatory requirements of the targeted countries are met. Work efficiently with CMC regulatory senior management to ensure coherence of strategies across projects.
• Lead the preparation of the CMC part of the dossier by collaborating closely with Pharmaceutical Development and / or Technical Operations teams, to generate effective CMC regulatory dossiers as per the project timelines.
• Write regulatory technical documentation including updating CTD sections with process and analytical data extracting information from reports, batch records, analytical procedures and quality events as appropriate.
• Work closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of the assigned projects and products.
• Anticipate any gaps for planned regulatory submissions, taking into account emerging regulations and country specific requirements, prioritising and planning associated regulatory strategies to address any identified gaps.
• Communicate with global regulatory lead to propose to de-risking some CMC strategic decisions through early communications and validation with worldwide health authorities.
• Lead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• Provide CMC regulatory expertise to project teams.
• Propose innovative CMC regulatory pathways to accelerate product delivery for patient enrolment in clinical studies, as required.
• Review of the Target Product Profile (TPP)/ Regulatory risk assessment/ Regulatory Strategy Document/ CCDS/ / Investigational brochures to ensure single aligned regulatory positioning and appropriateness of any CMC aspects, including paediatric (presentation, formulation, excipients) and ROW considerations, as required.
• Assess CMC-Regulatory impact of all changes proposed to the allocated product portfolio, providing strategic regulatory advice and clearly communicating any Regulatory impact and CMC-Regulatory supporting data requirements for subsequent variations/ amendments.
• Manage all Regulatory interactions for Site Registrations, Site Licences, Site master files s and site accreditations with Regulatory Authorities, Alliance partners and CMO’s for assigned product(s) as applicable.

CMC Dossier Preparation

• Ensure collaboration with teams in Pharmaceutical Development and in Technical Operations, as well as with Subject Matter Experts (SMEs) to deliver (coordination, authoring and review) effective, timely and compliant CTA (IND, IMPD), variations, responses to question and MAA modules 1, 2 & 3 in the correct “Ready For Submission” format for assigned products, in compliance with eCTD requirement.
• Work effectively with Global Regulatory Affairs (GRA) Therapeutic area, and GRA Regulatory Operations teams to ensure that CMC-Regulatory submissions comply with Ipsen group policies and procedures. Ensure that submissions are planned and scheduled appropriately to align with Technical Operations implementation requirements or clinical supply needs, while ensuring adequate time for review, approval and publishing tasks. Ensure the consistency of CMC data across the different modules of the dossier.
• Manage submission of annual reports for assigned product(s) as applicable.

CMC Regulatory expertise & Regulatory intelligence

• Participate and represent CMC regulatory strategy department in CMC project teams and Global project team, as necessary, for the assigned projects.
• Proactively provide Ipsen functions (e.g. Pharm Dev, TechOps, SMEs, GRA, Global project teams, etc) with CMC regulatory expertise.
• Communicate key regulatory CMC related guidance’s to Pharmaceutical Development/ technical Operations teams, SMEs and other stakeholders within Ipsen.
• Perform CMC-Regulatory Intelligence activities as required and work with cross-functional departments to ensure related operations are compliant.

Resources and performance

• Coach and develop junior resource within the regulatory strategic CMC Group.
• Lead and manage assigned projects and associated communication and reporting.
• Monitor and report on CMC Regulatory activities and process performance for the allocated products; identify areas for improvement, implement and monitor subsequent actions.

Communication

• Ensure the CMC-Regulatory Strategy Director/Senior Director, is provided with accurate and up-to-date CMC-Regulatory strategy for the assigned product(s).
• Assess CMC Regulatory activities and process performance, identify areas for improvement. Propose and lead continuous improvement process initiatives within the CMC-Regulatory Strategy function.
• CMC-Reg Strategy lead contact with sites, external Alliance partners and CMOs ensuring aligned strategy and optimised communication as applicable.
• Coach and develop junior resource within the CMC regulatory strategy team.

HOW - Behavioural Competencies Required

• Puts values and ethics at the forefront of everything.
• Anchors Ipsen's purpose, mission and commitments to patients and society.
• Identifies contradictory information/demands/inputs to effectively solve problems.
• Develops and evaluates alternative scenario and solutions.
• Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact.
• Methodically assesses, transparently shares, and makes risk-informed decisions.
• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society.
• Displays a commitment to sharing and implementing best practices and committed to excellence in execution.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Proven CMC Regulatory experience in managing small molecules and/ or biologicals in a worldwide environment “(approximately 3-6 years’ experience)”.
• Experience should include registration and clinical development (IND/IMPD) and/ or post-approval activities in US and EU and major RoW markets.
• Demonstrated experience in the development and implementation of global CMC-Regulatory strategies for major regulatory submissions.
• Strong project planning skills and ability to develop sound CMC-Regulatory strategy for multiple global changes.
• Proven advanced technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats and publishing support functions.
• Sound technical knowledge of the manufacture of pharmaceuticals and appropriate understanding of all regulatory CMC disciplines.
• Strong knowledge of current global regulatory requirements pertaining to the manufacture of pharmaceutical drug substances and drug products.
• Understanding of Pharmaceutical Quality activities and assessment of cGMP compliance, site registration and licensing.
• Proven experience in both internal and external Stakeholder management.
• Proven experience in handling multiple priorities and complex projects in a fast-paced environment.
• Analytical mindset and excellent attention to detail.
• Excellent critical thinking, written, verbal and interpersonal communication skills.

Knowledge & Experience (preferred)

• Experience with regulatory management of CMC activities for medical devices and maintenance of associated technical files including interactions with a Notified Body.
• Experience of Health Authorities interaction.
• Experience should include activities in export countries particularly e.g. China, Japan, Brazil.

Education / Certifications (essential)

• Advanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science).

Language(s) (essential)

• Fluent in English

Language(s) (preferred)

• Fluent