Senior Director Regulatory CMC Strategy - Biologics

Senior Director Regulatory CMC Strategy - Biologics

Ipsen Pharma

Boulogne-sur-Mer or London

Job Description:

Summary/purpose of the position

• 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 biologic cluster.
• Ensure the regulatory strategy related to CMC portion of Ipsen regulatory submissions for all Biologics portfolio worldwide is developed and implemented from early clinical trials to initial marketing applications, geo-graphical expansion, and life cycle management. Ensure timely and compliant submissions of CMC dossiers through efficient processes according to company’s strategy, business need and patients ‘interests.
• Accountable for early communication and validation from worldwide health authorities for any CMC strategic program and/or CMC questions across the biological products life cycle, in order to generate effective CMC regulatory dossiers and optimize time to market of new product and related changes.
• Accountable for ensuring compliance of CMC dossier of Ipsen’s products in all territories where Ipsen is the Marketing Authorization Holder.
• Accountable and responsible for delivering a transparent Governance structure for CMC regulatory operations ensuring the inclusion of upper management stakeholders within the Pharmaceutical Development, and Technical Operations teams.
• Provide strategic and operational leadership to his/her team and to R&D and TechOps upper management stakeholders; leading CMC regulatory interactions, preparation of submission dossiers, and active engagement with global/external CMC strategy forums and new guidelines in order to influence the regulatory environment.

Main responsibilities/job expectations:

CMC Regulatory strategy

• Work closely with global Ipsen regulatory community and particularly with Ipsen Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of Ipsen biologics portfolio (opportunities for ODD, fast track, breakthrough status, etc).
• Accountable for the definition and execution of the CMC regulatory strategy for new products in development and commercial assets; ensuring alignment with clinical programs and ensuring that regulatory requirements are met.
• Continuously evaluate the match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with R&D, Tech Ops, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or supply; proposes remediation where possible.
• Ensure coherence of strategies across projects of the biologics portfolio for worldwide submissions.
• Ensure regional regulatory specificities and needs are incorporated into the global plans.
• Bring innovative and compliant CMC regulatory pathway in the development of Ipsen biologics’portfolio.
• Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making.
• Define and execute strategy for early regulatory communication with worldwide Authorities and seek validation of innovative CMC regulatory strategy with Regulatory Agencies and CMCs KOL, maintaining active engagement with new guidelines.
• Accountable for the CMC regulatory section of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• Review of the Target Product Profile (TPP & QTPP)/ Regulatory risk assessment/ Regulatory Strategy Document/ CCDS to ensure single aligned regulatory positioning and appropriateness of any CMC aspects, including pediatric (presentation, formulation, excipients) and ROW considerations.
• Incorporate commercialization challenges into regulatory strategy (incl. trademark, licensing agreements, product sourcing, supply chain, distribution channels) beyond Marketing Authorizations (BLA etc).
• Consider regulatory avenues to maximize intellectual property protection and data exclusivity.
• Ensure CMC-Regulatory impact of all changes relating to the allocated product portfolio are assessed. Propose and communicate prioritization of changes to reflect company/department objectives.

CMC dossiers preparation

• Ensure collaboration with teams in Pharmaceutical Development/TechOps and Subject Matter Experts (SME) to deliver effective, timely and compliant CTA (IND, IMPD) , BLA, MAA modules 2 & 3 and corresponding variations/supplements in the correct format “Ready For Submission” for all biologics portfolio, in compliance with eCTD requirement and Ipsen Group Regulatory Affairs Dossier Management rules as required.
• Lead and take accountability for the CMC dossier generation process across all functions: ensure systems are in place so that each person in the CMC dossier process chain is clear as to their role, providing the right data in the right, ready-for-publishing format and in compliance with the authority requirement, and any applicable standard. Ensure alignment across all heads of functions.
• Accountable to provide GRA with ready-for-publishing CMC Dossiers in order to ensure effective, timely and compliant submission to Regulatory Authorities.
• Ensure any CMC question from regulatory authorities for our global markets are timely and efficiently responded to in order to reach submission approvals.

Compliance

• Ensure Ipsen dossiers contain relevant and accurate information per applicable standards.
• Ensure any gaps are appropriately identified and mitigated proactively.
• Ensure Ipsen Qualified persons are provided with guidance and clarity on the content of regulatory dossiers in order to ensure compliant release to market.

CMC Regulatory expertise & Regulatory intelligence

• Deliver global strategic CMC-Regulatory leadership to Ipsen functions on clinical trials, registration, lifecycle maintenance and post approval activities for all Ipsen biologic portfolio, through clear direction and mentorship to team leaders and members that are responsible for executing regulatory strategies.
• Identifies key risks to the business associated with submission strategy and supporting data packages and communicates to senior management well defined risk mitigation strategies
• Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to clinical trials, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications in alignment with regional requirements.
• Directs and communicates complex CMC Regulatory issues relative to Biologics portfolio independently at senior levels across the company and with external agencies and third parties as necessary ensuring alignment with business needs.
• Ensure representation in industry associations or working groups, as needed and drive Ipsen’s position on key topics with CMC Regulatory impact. Ensure company’s interests and positions are communicated to and taken into account by those external bodies. Ensure effective communication to stakeholders within Ipsen of any CMC Regulatory topic impacting the company.
• Provide regulatory expertise in Due diligence process for Biologics assets and provide CMC regulatory support/advice to in-licensing and divestment projects.
• Seat in Ipsen Strategic Committee such as Project Steering Committee, asset teams…to ensure CMC Regulatory strategy for Biologic portfolio is properly embedded in overall brand journey.

Resources

• Lead and develop the CMC regulatory Biologics team, manage resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspect to support clinical trials, initial submissions and life cycle management including change control requests.
• Manage talent selection, training, development, succession planning and performance management of the CMC regulatory Biologic team.
• Lead and manage assigned projects and associated communication and reporting.

Leadership & Communication

• Provide leadership, clear objectives and guidance in integrating CMC regulatory within business processes for Ipsen Biologic portfolio.
• Present CMC-Regulatory Strategic plans to business units and senior management
• Provide professional expertise and support to the company on Biologics CMC regulatory aspect.
• Prioritize CMC regulatory activities for Ipsen Biologic portfolio, managing resources to maximize business efficiency in alignment with strategic imperatives.
• Management of board scope of stakeholders within Ipsen (SME, VP, SVP and EVP) as well as management of External Business Partner for Ipsen and HA interactions.
• Build effective relationships with global/regional regulators for professional communication on Ipsen strategy in relation to our biologics portfolio.
• Actively contribute to the Regulatory Community life and contributes to process improvement initiatives on behalf of GRA.

Continuous improvement

• Define, implement and optimize interfaces across the CMC biologic dossier preparation process, particularly with the technical experts and other regulatory professionals (at global and local level).
• Seek for an optimized organization to ensure efficiencies and continuous improvement approach is embedded in the way the organization operate.

EHS Responsibilities

• Complies with applicable EHS regulations and procedures
• Participates in the site’s EHS performance by reporting risks, malfunctions or improvements
• Participates in mandatory EHS training

Knowledge, abilities & experience

Education/Certifications

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

Experience

• At least fifteen year’ experience in the pharmaceutical industry in various functions including Manufacturing, quality, pharmaceutical Development.
• At least 10 years’ experience in CMC regulatory R&D environment in a management role, writing CMC section of global regulatory filings.

Languages

• Fluent English

Key Technical Competencies Required:

• Thorough understanding of CMC dossier regulatory requirements (IND, CTA, BLA, MAA, etc.) from early clinical stage to life cycle management.
• Thorough knowledge of global industry standards/requirements related to EMA, FDA, and relevant government regulations and requirements.
• Proven experience in managing complex biological products (proteins/antibodies/toxins, medical devices/combination products) in a worldwide environment.
• Proven advanced technical and regulatory writing experience.
• Proven ability to lead teams and learn respect in a cross-functional global environment.
• Excellent written, verbal and interpersonal communication skills, highly organized.
• Strong analytical and problem-solving skills.
• Proven experience in successfully management of a broad scope of stakeholders internal, external (partners), and health authorities.
• Proven senior leadership capability.

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