VP, Head of Regulatory CMC
Boulogne, Cambridge, Paddington or Dublin
The VP, Head of Regulatory CMC will be responsible for all activities and strategic CMC aspects of Ipsen regulatory submissions both pre and post approval. This person will drive all CMC regulatory activities globally and provide the strategic guidance for global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval and ultimately support the life cycle of approved products, thus ensuring timely and compliant submission of CMC Dossiers through efficient processes according to company’s strategy, business needs and patients’ interests. This person will represent the regulatory function on multi-disciplinary product development teams and with external entities and lead and develop a team of approx. 30 people.
The VP, Head of Regulatory CMC will serve as a resource to team members for regulatory requirements, processes, and logistics to conduct global drug development activities. This includes developing and implementing the strategic CMC plans in collaboration with the Technical Operations and Quality Assurance teams, ensuring timely preparation, review, and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. With regards to regulatory submission, He/She will be accountable for Module 2.5 and 3 content for all products.
As a senior leader, the VP, Head of Regulatory CMC will liaise closely with stakeholders within R&D (including pharm dev and clin ops) and Technical Operations and will be a part of the GRA leadership team. The Head of CMC will also represent CMC in trade association for topics of interest.
CMC Regulatory Affairs Strategy
- Lead the CMC Regulatory Affairs activities and dossier generation in line with US, European, ICH and other applicable regulations;
- Coordinate with Technical Operations, Quality Assurance, and other functional areas to implement CMC regulatory strategy;
- Coordinate activities to support geographic expension (incl anticipation of shipment of samples);
- Represent the regulatory function on cross-functional development teams providing CMC regulatory guidance and strategy;
- Manage resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC Regulatory aspects to support lifecycle management and change control requests including transfer of supply within the company or with a CMO are delivered to agreed timelines;
- 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 Standards;
- Interact with CMOs and suppliers to implement CMC regulatory strategy;
- Represent IPSEN in trade association for topic of interest.
Strategic Guidance and CMC Leadership
- Deliver global strategic CMC-Regulatory leadership to Ipsen functions on registration, lifecycle maintenance and post-approval activities for commercial products as well as pre-approval activities for pipeline products, through clear direction and mentorship to team leaders and members that are responsible for executing regulatory strategies;
- Identify key risks to the business associated with submission strategy and supporting data packages and provides and communicates to senior management well defined risk mitigation strategies;
- Direct and communicate complex CMC-Regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary ensuring alignment with business needs;
- Ensure Ipsen CMC regulatory Operations is represented 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;
- Participate when required in due diligence activities and provide CMC regulatory support/advice to in-licensing and divestment projects;
- Ensure representation of CMC in Ipsen Strategic Committee such as DMAC, Project Steer Committee, Asset Teams etc.
Regulatory Submissions and Regulations
- Plan, prepare and review submissions to regulatory authorities including FDA, EMA, and other national authorities to support the conduct of clinical trials, submission of marketing applications and life cycle management;
- Ensure that regulatory documents are accurate, complete and in compliance with applicable regulatory requirements;
- Support the implementation of manufacturing processes, testing and process changes in accordance with cGMP and assessment of regulatory implications;
- Maintain current knowledge of relevant guidelines and regulations, determine the applicability to IPSEN programs and communicate this information to team members;
- Interface with regulatory authorities to drive development programs including preparing meeting requests and briefing documents and coordinating and preparing teams for meetings with regulatory authorities.
- Lead a global team of regulatory CMC professionals (located in France, US, UK, Ireland and China);
- Attract, develop and retain talents to shape the future of IPSEN;
- Prioritize CMC-Regulatory activities, managing global resources to maximize business efficiency in alignment with strategic imperatives;
- Oversee work with other functional area leaders and across project teams to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance;
- Seek for an optimized organization to ensure efficiencies and continuous improvement approach is embedded in the way the organization operate;
- Management of broad scope of Stakeholders within Ipsen (VP, SVP and EVP) as well as management of External Business Partner for Ipsen and HA interaction.
Ethics & Compliance
- Work closely with clinical and manufacturing departments and across project teams to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance;
- Ensure clear communication of project activities and progress in a timely manner;
- Ensure that adequate structures and controls are in place;
- Comply with Company guidelines and country/industry standards on ethics and compliance;
- Act as a role model displaying the 5 Ipsen Ways of Being;
- Ensure that all activities are undertaken in accordance with all Ipsen SOPs, policies, directives and relevant national guidelines.
- Minimum: BA/BS in scientific discipline (Pharmacy, Medicine, or Biological Sciences);
- Preferred Education: Masters or PhD in regulatory affairs, life sciences or relevant scientific discipline.
- 15 years of experience in the pharmaceutical industry in various functions including e.g. Regulatory Affairs, Quality, Manufacturing, QC and AD testing, Pharmaceutical Development;
- 10+ years of experience in CMC Regulatory Affairs experience in the biopharmaceutical industry in progressing leadership roles;
- Experience in the development of cell or gene therapies strongly preferred;
- Experience in providing strategic advice on the CMC regulatory development plans and executing the regulatory strategy;
- Thorough knowledge of global industry standards/requirements related to EMA, FDA, and relevant government regulations and requirements;
- Strong knowledge and experience in CMC product development and in-depth working knowledge of applicable regulations, guidance, and procedures;
- Previous experience in the preparation and submission of regulatory documents (IND/CTA/NDA/BLA/MAA);
- Significant experience in regulatory agency engagement and interaction;
- Proven experience in successfully leading cross-functional teams;
- Proven experience in successful management of a broad scope of internal and external stakeholders and Health Authorities;
- Proven senior leadership capability;
- Strong verbal and written communication skills.
- Fluent written and spoken English, French is a plus.
Key Technical Competencies
- Strong management and leadership skills with multicultural awareness and sensitivity: ability to manage and lead teals both with and without solid reporting line, proven collaboration skills with the ability to obtain to influence without authority. Possesses a high degree of credibility by gaining trust and confidence of others;
- Strong interpersonal skills: ability to successfully interact with all levels of the company including Senior Leadership teams and with external bodies (Regulatory Authorities, Alliance partners, contractors, industry associations…);
- Proactive, forward thinker with a creative and solutions-mindset, sees ahead clearly, able to think innovatively about regulatory strategy, can anticipate future consequences and trends accurately, has broad knowledge and perspective; is future-oriented, can articulately paint a credible picture and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans;
- Provides the highest quality of regulatory strategy and operations through continuous improvement and empowerment; creates a learning environment leading to the most efficient and effective work processes;
- Excellent written and oral communication skills; ability to distil key information from complex and extensive sources and present the information in a positive way.
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