Senior Director, Regulatory Affairs CMC Small Molecule

Position Summary

• Coordinate the preparation of module 3 of the NDA and MAA for Pelabrisib by providing strategic Regulatory CMC advice to dossier authors, implementing dossier templates and leading comment resolution meetings. Responsible for authoring module 2.3.
• Develop CMC regulatory strategy and communicate critical issues to Senior Management.
• Ensure the development strategy meets global regulatory requirements over the lifecycle of the product.
• Ensure CMC regulatory strategy is in alignment with global regulatory strategy, commercial strategy, and the Quality Target Product Profile (QTPP)
• Assure connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs
• Participate as the Regulatory CMC Lead on CMC Teams (as appropriate) and represent CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.
• Escalate issues to Regulatory Affairs Management that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Review and approve regulatory dossiers for submission to Health Authorities
• Actively participate on Regulatory Team(s) to develop global marketing approval submission plans.
• Provide accurate regulatory assessments of chemistry, manufacturing and controls changes to teams/projects and execute regulatory planning and implementation.
• Participate in and conduct due diligence/licensing evaluations as needed.
• Manage a staff, including objective setting and career development activities.
• Represent Regulatory Affairs on governance committees.

Minimum Education/Skills/Experience

• Hold an Advanced Degree (PhD, Pharmacy, MSc or similar)
• 15+ years of professional experience in the pharmaceutical industry in CMC development, with a minimum of 10 years in CMC Regulatory Affairs
• Experience developing regulatory strategies and an understanding of product development
• Hands-on experience in preparing the quality part of the NDA/MAA
• Experience leading interactions with Health Authorities
• Strong knowledge of global HA laws, regulations, guidance, and global regulation submission routes available for new study drugs
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
• Experience in communicating cross-functionally and present and defend CMC regulatory strategy and opinion to project teams; recognizes global regulatory impact
• Demonstrate model behavior that understands what the priorities are and encourages others to drive for results

Culture & Benefits

As a full time, employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more.  We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program.  Our culture is a collaborative work environment, and we believe the unique contributions each of us brings drives our success

Health and Safety

Full vaccination against COVID 19 is a requirement for this position.

EEOC Statement

MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices.  We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.

Reasonable Accommodations

MorphoSys is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at hr-us@morphosys.com