CMC Director

2 weeks ago


Dublin, Dublin City, Ireland Scientificjobs Full time

CMC Director
Our client, clinical-stage biopharmaceutical company are currently recruiting for a CMC Director to join their team on a permanent basis. As CMC Director, you will coordinate, manage and provide technical oversight of the CMC team responsible for the development of drug substance, drug product and analytical methods.

Responsibilities:

Coordinate a technical team in the execution of a complex combination product development program working collaboratively within the cross functional team structure Accountable for development of the drug substance synthesis process, drug product manufacturing, and the development of associated analytical methods Develop and maintain the CMC Pharmaceutical development plan and budget, including all DS, DP and Analytical Development work packages Implement the CMC strategy including vendor selection and management, clinical and commercial supply chain strategy, second source supply strategy and risk management Manage CMC program risks and issues, evaluate contingency plans and risk mitigation activities, while ensuring effective communication with senior managementAuthor and review of Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, meeting requests, and briefing documents) Requirements:
Minimum of Masters degree in relevant scientific discipline required, with 12+ years industry experience including R&D and / or Technical Development Strong understanding of ISCH guidance's across all relevant disciplines. An understanding of ISO 13485 and FDA regulations on drug-device combination product development is advantageous Prior experience in working on combination product development programs essential Experience in development of products for pulmonary delivery preferred Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team An entrepreneurial, business-oriented mindset and willing to "roll their sleeves up" attitude A self-starter and comfortable working on their own initiative Ability to perform multiple tasks simultaneously under direction and prioritise workload Maintain a professional and positive attitude and present clear instruction/direction to team members Prov

  • Dublin, Dublin City, Ireland Viatris Full time

    Director Global CMC Strategy – Based Anywhere in EuropeJoin to apply for the Director Global CMC Strategy – Based Anywhere in Europe role at ViatrisDirector Global CMC Strategy – Based Anywhere in Europe2 days ago Be among the first 25 applicantsJoin to apply for the Director Global CMC Strategy – Based Anywhere in Europe role at ViatrisGet...


  • Dublin, Dublin City, Ireland beBee Careers Full time

    Job Title: Regulatory Affairs Director - CMC Lead">Description: In this key role, you will be responsible for leading project-driven regulatory interactions with health authorities. Key aspects of the job include seeking scientific advice from regulatory bodies such as the FDA and EMA.">About You: We are looking for a proactive individual who is eager to...


  • Dublin, Dublin City, Ireland Infoempregos Full time

    Job Description:Lead project-driven regulatory interactions with health authorities, e.g., FDA, EMA, for CMC scientific advice.We are looking for a young talent to join our team in a position with no previous experience required. If you are proactive and eager to learn, contact usRequirements:- Willingness to learn and adapt to new challenges.- Good verbal...

  • CMC Manager

    3 weeks ago


    Dublin, Dublin City, Ireland The RFT Group Full time

    Social network you want to login/join with:Our client is young ambitious pharmaceutical company with a strong record of success in drug development. The newly appointed CMC Manager will report to the Associate Director – Technical Operations and will manage pharmaceutical development and pharmaceutical technology projects to deliver development pipeline...

  • CMC Manager

    2 weeks ago


    Dublin, Dublin City, Ireland The RFT Group Full time

    Job Description Interview Report North Leinster Our client is young ambitious pharmaceutical company with a strong record of success in drug development. The newly appointed CMC Manager will report to the Associate Director – Technical Operations and will manage pharmaceutical development and pharmaceutical technology projects to deliver...


  • Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Affairs Specialist: Leading the Way in Pharmaceutical RegistrationThis is a full-time/hybrid position that reports to the Global Regulatory Affairs Associate Director.The successful candidate will be responsible for planning, executing, tracking, and reporting on assigned operational registration and life-cycle management projects for company...


  • Dublin, Dublin City, Ireland beBeeRegulatory Full time

    Regulatory Affairs LeadA challenging opportunity has arisen for an experienced Regulatory Affairs Manager to join our team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.Job DescriptionTo take lead role and responsibility for the effective planning, execution, tracking and reporting of assigned...


  • Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Affairs SpecialistThis is a full-time/hybrid position reporting to the Global Regulatory Affairs Associate Director.The role involves leading operational registration and life-cycle management projects for company products, promoting high-quality regulatory best practices, strategy definition, process efficiencies, effective communication, status...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    JOB DESCRIPTION FORM Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities: To take lead role and responsibility for...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    JOB DESCRIPTION FORM Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities: To take lead role and responsibility for...