Senior Manager CMC Regulatory

POSITION

Job Title:

Senior Manager, CMC Regulatory Strategy Biologics

Division / Function:

Global Regulatory Affairs (GRA)

Manager's Job Title:

Director/Sr Director CMC Regulatory Strategy Biologics

Ipsen Job Profile:

Regulatory CMC

Location:

Paris, FR & Paddington, UK

WHAT - Summary & Purpose of the Position

Responsibility for CMC regulatory strategy for the assigned biological projects throughout the different phases of development from early clinical trials to initial marketing applications, geo-graphical expansion, and life cycle management.

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

Provide CMC regulatory expertise to R&D & TechOps project teams and lead CMC regulatory interactions for the preparation of submission dossiers and support the development of junior CMC-reg colleagues.

WHAT - Main Responsibilities & Technical Competencies

• CMC Regulatory Strategy
• 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 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.
• Work closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of all assigned projects.
• Define and execute the CMC regulatory strategy roadmaps for all products in scope (R&D or LCM) ensuring that regulatory requirements are met. Work closely with CMC regulatory senior management to ensure coherence of strategies across projects.
• Ensure regional regulatory specificities and needs are incorporated into the global plans incl. emerging regulations.
• Participate in gap/risk analysis activities as needed, prioritising and planning associated regulatory strategies to address any identified gaps/risks. 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.
• Propose innovative CMC regulatory pathways to accelerate product delivery for patient, as required.
• Communicate with global regulatory lead to propose de-risking through early communications with worldwide health authorities.
• Lead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• 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 pediatric (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.
• Contribute to the development and maintenance of efficient, compliant and robust systems, procedures and processes.

• Manage all Regulatory interactions for Site Registrations, Site Licences, Site master files, annual reports 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/ Technical Operations and Subject Matter Experts (SME) to deliver (coordination, authoring and review) effective, timely and compliant CTA (IND, IMPD) and MAA modules 1, 2 & 3 in the correct format "Ready For Submission" for Ipsen products portfolio in compliance with eCTD requirement and Ipsen Group Regulatory Affairs Dossier Management rules as required.
• 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.
• Responsible for the CMC dossier generation process across all functions: ensure the role of each function involved in the generation of the CMC dossier is clear and will provide accurate data with the correct level of detail in compliance with regulatory requirement.
• Manage timely and efficiently the Response to CMC questions from National Health Authorities worldwide with support from Pharmaceutical Development/ technical Operations teams and Subject Matter Experts (SMEs) as necessary to reach submission approval.

• Prepare and maintain the necessary CMC trackers, monitor progress using KPIs and provide regular updates to the team.

• 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.
• Participate in the monitoring of the external environment to identify trends and assess potential impact on business and communicate this information to stakeholders.

• Actively participate in Industry associations or working groups and ensure company's interests are taken into account.

• 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

• Establish and maintain an excellent working relationship with Pharm Dev/ TechOps teams and the Ipsen regulatory community, in particular with Ipsen Global Regulatory Affairs Therapeutic Area Leads, European and intercontinental leads, Regulatory Operations Publishers and Ipsen affiliates/partners to ensure efficient coordination of regulatory submissions.
• Lead contact with external Alliance partners and CMOs ensuring aligned strategy and optimised communication.
• Build effective relationships with global/regional regulators through agencies meetings, scientific advice and scientific workshops to ease validation on Ipsen strategy.
• Ensure the CMC-Regulatory Strategy Director/Senior Director, is provided with accurate and up-to-date CMC-Regulatory strategy for the assigned product(s).
• Actively contribute to the Regulatory Community life.

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 direct experience in CMC regulatory environment in pharmaceutical industry dealing with Biological/Biotechnological modalities ("approximately years' experience)".
• Proven experience in managing CMC-regulatory activity for products in a worldwide environment.
• Proven experience in CMC regulatory on R&D and/or LCM portfolio.
• Experience of Health Authorities interaction. Proven advanced technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats and publishing support functions.
• Proven ability to learn respect in a cross-functional global environment.
• Proven understanding of CMC regulatory processes and requirement in US, EU, and export countries e.g. JP, China, Brazil, Russia….
• Excellent written, verbal and interpersonal communication skills, highly organized
• Ability to handle multiple priorities and complex projects in a fast-paced environment.
• Strong analytical and problem-solving skills.

Knowledge & Experience (preferred):

• CMC Regulatory experience with Biological/Biotechnological modalities
• Some technical experience in process development or analytical development of Biological/Biotechnological products.

Education / Certifications (essential):

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

Language(s) (essential):

• English: fluent

Language(s) (preferred):

• French fluent