This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated. Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early stage development programs or working with the Regulatory CMC Lead for late stage development or commercial programs. The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities, as delegated.
- This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, Regulatory CMC knowledge and interpersonal skills are required.
Job Duties: - Providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
- Preparation and delivery of CMC Regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (including IND/IMPD/CTAs/MAAs)
- Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities.
- Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions
- Managing CMC aspects of routine and non-routine Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
- Monitoring changes in the Regulatory CMC environment to support and advise key stakeholders and teams.
- Providing input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy.
- Coordinating and completing regulatory assessments of CMC changes in the designated systems
- Responsible for assuming responsibilities from the Team Lead or Global Regulatory CMC lead, as agreed and delegated and maintaining open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions.
- Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of Regulatory CMC on cross functional work streams
- Responsible for leading or assisting in delivery of Regulatory CMC initiatives and the development of Regulatory CMC standards and SOPs, as assigned.
- Ensure that appropriate records are maintained in the designated system for submission in assigned regions
Regulatory skills - At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
- Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products (biological, oligonucleotide, and/or chemical entities)
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products
- Experience of direct communication and negotiation with regulatory agencies on CMC matters
- Knowledge of GMP requirements and standard systems (e.g. change management systems)
- Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
Leadership/Management Skills - Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones.
- Ability to influence cross-functional stakeholders to ensure execution of optimal RegCMC strategy
- Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
- Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
- Demonstrated competency in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
- Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.
- Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.
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