CMCD Individual Contributor
- Develops global regulatory CMC strategies and risk assessments for development projects and/or marketed products ( new or marketed chemical entities, biological entities, vaccines and/or consumer health care products) in collaboration with other parts of GRA. Assures effective involvement with change control systems. Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
- Assures that appropriate contacts with Health Authorities , in collaboration with Country Regulatory Groups , are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships. Responsible for direct contact/liaison with US FDA and EMA on specific CMC topics. Supports strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).
- Manages or directly contributes to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with R&D Functions, Industrial Affairs Functions and GRA Regulatory Operations. Assures that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved. Assures that technical and regulatory CMC issues are appropriately resolved with optimal solutions. As applicable, support the regulatory inspection process for development projects and marketed products.
- Contributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate client visibility and input is recognized. Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers. Assures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated.
Knowledge, Skills & Competencies / Language
Global operational experience with a mid/large-size Regulatory CMC and Devices Organization. Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues. Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences. Fluency (oral and written) in English language is strongly recommended. Potential to be able to mentor and train staff is desirable but not essential.
Minimum of a Bachelor’s Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable.
Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable. Typically, an additional 1-5 years of direct Regulatory CMC experience is preferred. However more than 5 years may be applicable for certain associates within an individual contributor career path. Experience working for a Regulatory Health Authority is helpful but not essential.