Job Detail

Job Description

• Providing regional 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 (in the clinical, initial marketing, or post-approval phase. )


• Responsible for regional submission from defining and agreeing content with CMC global regulatory lead to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities in assigned regions.


• 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 regional Health Authority interactions including issue resolution and negotiation of approvals, as delegated.


• Monitoring changes in the regulatory CMC environment in assigned regions to support and advise CMC global lead and teams.


• Providing input into regulatory CMC risks assessment and mitigation plans from a regional perspective for assigned regions 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 global regulatory lead, as agreed and delegated and maintaining open lines of communication with the lead on assigned projects/products to ensure awareness on status and issues relating to regional submissions.


• Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of RegCMC on cross functional work streams


• Responsible for leading or assisting in delivery of RegCMC initiatives and the development of RegCMC standards and SOPs, as assigned.


• Ensure that appropriate records are maintained in the designated system for submission in assigned regions.

Qualifications

Regulatory Skills

• At least 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, and quality assurance/control or related technical field.


• Successful authoring and contribution to delivering CMC submission documents of development and 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 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.


• 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.


• Recognized experience in project and timeline management. Experience with clinical development and associated regulatory CMC submissions.


• BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.

Additional Information

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 biologics projects, working as or working with the CMC Global Regulatory Lead and key stakeholders, primary contact for affiliates on regulatory CMC activities in the assigned regions and managing of routine and non-routine regional Health Authority interactions as delegated by the CMC global regulatory lead. Depending on the stage of development and complexity of the program, this role can be an CMC Global Regulatory Lead for early-stage development programs or working with the CMC Global Regulatory Lead for late-stage development programs.

The Regulatory CMC Clinical lead is the primary global contact for regulatory CMC activities associated with the program.  For late-stage development programs the Regulatory CMC Clinical lead is the primary contact in the assigned regions (US, Canada, Latin America where located in the USA and EU, MENA, APAC where located in the Europe). 

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.