Vice President, Regulatory Affairs (527)

Essential Duties and Responsibilities

• Lead the Regulatory CMC function to support the CMC portfolio goals with proven track record of successfully building and leading teams.
• Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses.
• Leads and represents Civica in regulatory meetings.
• Strengthen biologic / biosimilar and sterile injectable CMC capability by working with internal stakeholders and external partners to evaluate and enable biosimilar approvals.
• Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
• Exercise expertise in the interpretation and implementation of FDA guidelines with a goal of an approved / harmonized regulatory control strategy.
• Ensure regulatory conformance & consistency for assigned products in compliance with regulatory requirements and internal procedures.
• Oversee regulatory affairs operations including the VEEVA regulatory information management (RIM) platform, and the artwork management system for both Civica owned and private label distribution products.
• Partner across the CMC functions in the company, and other functional groups at Civica to support opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
• Develop meaningful and collaborative relationships with internal / external partners.
• Demonstrate success in influencing without positional authority within a highly matrixed organization.

Basic Qualifications and Capabilities :

We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest of our patients.

What we look for :

• A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA / BS, MA / MS, PhD or PharmD.
• Demonstrated organizational leadership skills at both functional and enterprise levels.
• Experience with leading NDA / ANDA / BLA / IND / IMPD / CTA submission and approvals including Health Authority interactions.
• Application of sound and accurate judgment to make timely decisions.
• Biologics / biosimilar and sterile injectable experience is preferable.
• Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory / industry forums for topics of external policy relevance (e.

g., ICH, PhRMA, ISPE, IQ, Bios, etc.).

• Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
• Excellent strategic acumen, collaboration, and communication skills are required.
• Excellent interpersonal, verbal, and written communication skills.
• Proven success in :
• Strategic thinking capability with business acumen to allow an understanding of how the parts impact the enterprise
• Direct support of the submission and approval of regulatory applications, amendments and changes including resolution of information requests
• Large scale quality management experience including the design and implementation of effective and compliant quality processes, procedures and tools
• Exceptional problem-solving skills to foster the development and implementation of risk-based compliant solutions to business and regulatory challenges
• Providing quality and regulatory input across the development and product lifecycle
• Process and analytical development and commercial knowledge to facilitate root cause analysis and effective solutions and corrective measures
• Building and maintaining complex collaborative relationships capable of influencing the delivery of aligned compliant solutions and decisions
• Creating a future vision and gaining support and alignment to that vision
• Building consensus and impact outcome without always having line authority
• Negotiating trade off decisions across the organization

Physical Demands and Work Environment :

Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site.

Travel of up to 20% may be required.