| The Global Regulatory Affairs CMC Team Lead manages, oversees and develops a team of CMC regulatory professionals and is accountable for all CMC regulatory activities related to product development, registration and license maintenance for the products handled by the team are as follows: For the product portfolio overseen by the team, the GRA CMC Team Lead is also accountable for development and implementation of global CMC regulatory strategies for development and life cycle projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements. Additionally, the position holder might bear operational and strategic CMC regulatory responsibility for products assigned to him/her personally, and in this role will be a permanent member or oversees team members of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s) related to the assigned products. For established products which are no longer in clinical development he/she may be appointed as Global Regulatory Lead. In this role, he/she will chair a GRAST and be accountable for successful product lifecycle management. The position holder is accountable and responsible for the oversight of his/her team’s timely regulatory assessment of all CMC changes, technical changes related to facility and equipment and/or plasma changes in the Global Change Control (GCC) system in accordance with global regulatory requirements and in close cooperation with GRA Regions. The position holder is accountable and responsible for the oversight of his/her team’s compilation and maintenance of facility and equipment information for regulatory submissions. He/she is the primary GRA contact during GMP inspections and for preparation of inspections. Job Description 1. Responsible to establish and maintain a team of regulatory affairs professionals working in an efficient, productive and harmonized fashion to be the CMC regulatory experts for the products and projects overseen by the team. Ensures consistent approaches and development of best practices. 2. .Accountable for all CMC regulatory development and product life cycle management activities related to the team’s product portfolio, including as applicable: - Maintenance of the content of relevant parts of the regulatory dossiers.
- Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g. MAAs, BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation.
- Timely provision of high quality responses to CMC related Health Authority questions.
- Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs).
- Provision of timely and compliant regulatory assessments as well as efficient execution of CMC changes, technical changes related to facility and equipment and/or plasma changes.
- Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials.
- Regulatory contribution to annual product quality reviews and risk assessments.
3. Accountable for planning and execution of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects related to the team’s product portfolio with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements. Provides tactical regulatory leadership and guidance to ensure, optimal regulatory strategies are achieved in an aligned and efficient fashion. Ensures they are complete, accurate and consistent with project objectives. 4. Responsible for all operational and strategic CMC regulatory activities for directly assigned products, including as applicable: - Is a permanent member or oversees team members of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s) related to the assigned products.
- May represent Global Regulatory Affairs in Core Project Teams for CMC projects affecting the assigned products.
- Is responsible for all CMC regulatory development and product life cycle management activities related to the assigned products, comprising the activities listed in section 2 above as applicable.
- Is responsible for planning and execution of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects related to the assigned products.
- Is the primary GRA contact point interfacing with relevant technical expert departments for project planning purposes, compilation and updates of technical documentation and for addressing CMC regulatory questions related to the assigned products.
- Evaluates the technical and scientific CMC information available for the assigned products for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks.
- Supports scheduling and prioritization of CMC related submissions for the assigned products.
5. May be appointed as Global Regulatory Lead for established products which are no longer in clinical development. This responsibility includes: - Chairs the related Global Regulatory Strategy Team(s) (GRAST(s)).
- Is accountable for the regulatory contribution to successful product lifecycle management in alignment with key internal stakeholders (e.g. Commercial, Operations, Safety).
- Leads and oversees the development and alignment of global regulatory strategies for product lifecycle management activities within the GRAST. Ensures integration of regional regulatory requierements, adequate documentation and pro-active adaptation of strategies to ensure incorporation of new information and start-of-the-art regulatory intelligence.
- Coordinates and tracks compilation of regulatory documentation required to support new product registrations and relevant lifecycle submissions (e.g. renewals) within the GRAST.
- Oversees scheduling and prioritization of all regulatory submissions for the assigned products.
- As required, presents regulatory strategies, risk assessments and mitigation proposals to senior review committees such as GRA Strategy Management Review Team (SMRT) or Global Lifeycycle Review Board (GLRB).
6. Accountable and responsible for the timely regulatory assessment of CMC changes, technical changes related to facility and equipment and/or plasma changes in the Global Change Control (GCC) system in accordance with global regulatory requirements and in close cooperation with GRA Regions. First contact point for relevant local technical expert departments regarding regulatory questions related to change control. May represent GRA in local and global change panels. May represent GRA in local change projects affecting multiple products, coordinates and consolidates input from all relevant regulatory functions. 7. Accountable and responsible for the compilation and maintenance of facility and equipment information for regulatory submissions. Acts as primary GRA contact point interfacing with relevant local technical expert departments. May represent Global Regulatory Affairs in Core Project Teams for CMC projects as an expert for regulatory questions related to facility and equipment. Serves as a designated GRA contact during GMP inspections and for preparation of inspections. Coordinates all incoming questions from an inspection within GRA, asseses and communicates inspectional findings and supports CAPA projects as applicable. 8. Accountable for the regulatory part of CSL Behring’s international active substance and excipient business for assigned customers. Ensures the management of regulatory processes and procedures in collaboration with the customers to support their registration activities. Ensures regulatory support for new customer acquisition and contract negotiations (supply and quality agreements) by conducting regulatory due diligence/feasibility evaluation of new business opportunities, as required. Ensures that registration activities are aligned to CSL Behring’s business needs. 9. Leadership Responsible to supervise, mentor and develop the team members. Supports pro-active planning and management of resources in line with Global Regulatory Affairs activities and priorities. Contributes to scheduling and prioritization of submissions related to the products and projects overseen by the team. Contributes to the development of global regulatory processes. Interprets existing or new regulatory requirements, evaluates draft guidelines and writes impact assessments. If required, deputizes for the GRA CMC Site Lead 10. People Management Organizes, coordinates and manages the team to meet CSLs business needs: - Sets clear expectations and objectives and drives performance.
- Conducts annual performance evaluations, gives feedback and recognizes achievements
- Participates in the interviewing and hiring process of candidates (both internal and external) for open positions.
- Arranges for training and orientation of new regulatory affairs staff in accordance with CSLs global, regional and local SOPs
Position Qualifications and Experience Requirements: Education University degree in natural sciences (BS, MS or equivalent), a Ph.D. or further degree, e.g. in Regulatory Affairs is advantageous. Experience - Minimum of 7 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs.
- Minimum of 1-3 years’ experience in leading and managing a team or matrix team, setting clear direction, holding people accountable and thus fostering a result oriented and collaborative team working environment.
- Sound knowledge in natural sciences with a focus on biological medicinal products.
- Sound technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, CH, Australia).
- Knowledge in Good Manufacturing Practice or related areas would be highly regarded.
- Ideally, experience in working cross-culturally within a complex or matrix environment.
Competencies - Excellent communication, project management, planning, problem solving and presentation skills.
- Strong team player with a demonstrated ability to develop constructive and effective relationships with peers and management.
- Keeps a team focused to deliver according to agreed milestones, can inspire and motivate while providing corrective feedback, if required.
- Strong organizational and follow-up skills, as well as attention to detail.
- Able to take decisions and to work with minimal supervision based on sound technical and analytical judgment.
- Flexibility to work in a global cross-cultural work environment.
- Fluent in English and local language.
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