Beschreibung

In this role, you will lead regulatory support for CMC programs, ensuring effective strategies for global submissions. Your daily responsibilities will include collaborating with teams, managing documentation, and maintaining relationships with regulatory authorities to drive project success.

Anforderungen

• •10-12+ years of related work experience
• •8+ years in Regulatory Affairs CMC in Biotech/Pharmaceutical industry
• •Experience in small molecule drug development
• •Experience in cardiovascular therapeutic area
• •Proven experience as primary RA-CMC contact to Health Authorities
• •Bachelor’s degree in chemistry or related field
• •Advanced degree preferred
• •Excellent working knowledge of international regulatory requirements
• •Solid working knowledge of core processes in small molecules
• •Experience with eCTD requirements and electronic submissions
• •Experience with international regulatory submissions
• •Ability to work effectively across teams and functions
• •Excellent oral and written communication skills
• •Excellent organizational skills and attention to detail

Aufgaben

• •Formulate CMC regulatory strategies based on current regulatory intelligence
• •Collaborate with cross-functional project teams to develop CMC regulatory strategies
• •Identify regulatory risks and represent the department in project teams
• •Determine required documentation and manage delivery of approved technical documents
• •Prepare, author, and maintain regulatory submission documents for global applications
• •Evaluate manufacturing changes for potential product impact
• •Review CMC documentation supporting regulatory submissions and communications
• •Coordinate responses to queries from regulatory authorities focused on CMC
• •Maintain knowledge of FDA/EMA regulations and ICH guidelines
• •Ensure conformance to commitments made with regulatory agencies
• •Provide regulatory advice to other functional areas
• •Participate in regulatory due diligence activities
• •Build and maintain relationships with internal and external business partners
• •Develop collaborative relationships with other departments for effective communication
• •Manage relationships with external vendors and regulatory health authorities
• •Coordinate meetings and conferences with FDA, EMA, and other regulatory authorities
• •Collaborate with regulatory colleagues to provide CMC expertise
• •Develop and implement regulatory operating guidelines and strategies within the team