Associate Director, CMC Global Regulatory Lead (CMC GRL)
J ob Description: This role is responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development and/or commercial programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific small molecule programs, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program.
This is a dual role of the CMC GRL and the CMC Regional Regulatory Lead (CMC RRL) in the region in which the CMC GRL is located. In addition to the accountabilities and responsibilities presented, the CMC GRL also assumes the role and responsibilities of the CMC Regional Regulatory Lead (CMC RRL) for assigned projects/products in the region in which the CMC GRL is located.
The CMC GRL provides regulatory CMC leadership on the cross functional sub teams (regulatory science project teams, asset teams) and advises on best practices and/or supports PDCs.
The CMC GRL is responsible for managing line reports (if applicable) and providing input to Global RegCMC initiatives and cross functional work streams as assigned by the Global RegCMC LT.
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.
Duties and Responsibilities:
- Accountable for strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions.
- Ensures that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.
- Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
- Leads cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.
- Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams.
- Highlights and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
- Facilitates capture and communication (within and outside of Global RegCMC) of CMC lessons learned from major submissions for assigned projects/products.
- Accountable for all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with HAs in all regions.
- Establishes and maintains modes of effective communication and collaboration with the teams assigned projects/products.
- Partners with regulatory regional leads for exchange of project/product related information and submission planning.
- Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
- Monitors and influences changes in the global Regulatorily CMC environment in alignment with business needs.
- Defines and communicates the need for internal and/or external regulatory CMC resource to the Global RegCMC LT as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines.
Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.
Represents Global RegCMC on due diligence and divestment teams as assigned by the Global RegCMC LT.
Leads or provides input to Global RegCMC initiatives and cross functional work streams as assigned by Global RegCMC LT.
Participates in skill development and coaching of other Global RegCMC Team members as required.
Responsible for management, coaching and development of direct reports as applicable.
Education: BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 5+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities.
Direct experience in generation of MAA including Regulatory strategy, Agency interaction and Module 3 content for innovator company.
Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
Knowledge of global guidance, regulations and ICH/GMP requirements
Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
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 planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.
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.
Competence in people development and management.
Preferred/Additional: Recognized experience in project and timeline management. Small molecule, partnership/coloration and direct global MAA submission experience. Chemistry background
This role is responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development and/or commercial programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific small molecule programs, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program.
Key Contacts and Interactions: Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels.
Customer focused: Interacts with key stakeholders both internally and externally, including subject matter experts, partners and regulatory agency personnel.
This role is office based in Baar, Switzerland