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Solid experience in global CMC regulatory from local/ global pharma or relevant experience

Expertise in global CMC regulatory requirements for post-marketing variations

With strong experience in biologicals (vaccines preferred) for EU and US FDA.

We are seeking an experienced Senior Associate level of Regulatory CMC to join our team. In this role, you will be responsible for developing CMC strategies and managing regulatory submissions for both early-stage programs and marketed products. The ideal candidate will have extensive experience in authoring and reviewing regulatory submissions, performing regulatory assessments of manufacturing changes, and representing Regulatory CMC in cross-functional teams.

Key Responsibilities:

Regulatory Strategy and Submissions:

• Develop comprehensive CMC strategies for early-stage programs and marketed products

• Author and review regulatory submissions, including:

• Investigational New Drug (IND) applications

• Investigational Medicinal Product Dossiers (IMPDs)

• Post-approval variations/supplements

• Annual reports

• Responses to health authority questions

• Ensure all submissions conform to relevant health authority guidelines and regulations

• Lead submission preparation meetings and coordinate cross-functional input

Regulatory Assessment and Change Management:

• Perform regulatory assessments of manufacturing changes

• Establish data requirements for regulatory submissions related to manufacturing changes

• Provide expert guidance on CMC-related regulatory implications of proposed changes

Project Management and Leadership:

• Represent Regulatory CMC at project team meetings

• Lead submission preparation meetings

• Address reviewer comments and manage regulatory correspondence

• Provide regular updates to Management on project status and key milestones

• Mentor junior team members in Regulatory CMC practices

Cross-functional Collaboration:

• Work closely with various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development

• Facilitate effective communication between internal teams and regulatory authorities

• Provide CMC regulatory expertise to support business decisions and product development strategies

Regulatory Intelligence:

• Stay current with evolving CMC regulations, guidelines, and industry best practices

• Contribute to the development and implementation of internal CMC regulatory policies and procedures

• Participate in relevant industry groups and regulatory authority meetings as needed

Qualifications:

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field (Ph.D. preferred)

• Minimum of 8+ years of experience in Regulatory Affairs, with a strong focus on CMC

• Extensive knowledge of global CMC regulatory requirements and submission processes

• Proven track record of successful regulatory submissions and interactions with health authorities

• Strong understanding of pharmaceutical development, manufacturing processes, and quality systems

• Experience with both small molecules and biologics is highly desirable

• Excellent project management skills with the ability to manage multiple projects simultaneously

• Strong analytical and problem-solving skills

• Outstanding written and verbal communication skills

Desired Qualities:

• Strategic thinker with the ability to anticipate and address potential regulatory challenges

• Strong leadership skills with the ability to influence cross-functional teams

• Proactive and self-motivated with a commitment to excellence

• Adaptable to changing priorities and evolving regulatory landscapes

• Excellent interpersonal skills with the ability to build strong relationships with internal and external stakeholders

• Detail-oriented with a focus on quality and accuracy

If you are an experienced Regulatory CMC professional with a passion for developing and implementing effective regulatory strategies, we invite you to apply for this key role in our organization. Join us in ensuring the successful development and commercialization of our products through expert regulatory guidance and leadership.

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.