Associate Director/Director CMC Product Development(m/w/x)

Deine Aufgaben

• •Represent CMC areas on the AST and ensure information flow.
• •Ensure high-quality science and compliance with regulations.
• •Participate in meetings with Regulatory Authorities and respond to queries.
• •Create CMC development plans with timelines, risks, and mitigations.
• •Lead PPDST and CMC development teams for assigned projects.
• •Conduct periodic reviews to meet phase transition criteria efficiently.
• •Review contracts with Third Party Manufacturers and consultants.
• •Develop budget needs and obtain resources from functional areas.
• •Drive legal and financial aspects of outsourcing and contracts.
• •Demonstrate excellent interpersonal skills with external partners.
• •Exhibit strong negotiating, influencing, and leadership skills.
• •Lead teams for new due diligence in-licensing opportunities.
• •Manage a limited number of complex projects using matrix management.
• •Negotiate for additional resources and influence project timelines.
• •Implement creative approaches to conserve resources and achieve efficiency.
• •Provide feedback to functional managers and identify team growth needs.
• •Ensure strategic alignment with key Development Sciences functions.
• •Integrate and implement pre-clinical development plans with global teams.
• •Support CMC functional initiatives and across-asset strategies.
• •Promote scientific thinking and manage quality and results.
• •Ensure compliance with regulatory, health, safety, and environmental requirements.
• •Stay updated on global technical, regulatory, and compliance developments.
• •Apprise management of plans and risks through regular communications.
• •Ensure quality and effectiveness of dossiers for health authorities.