COMPLETE GRA CMC Lead for Small Molecules and Complex Non-Biologic Drug Products - EMEA, CH, Kanton Zurich, Opfikon, CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.

We are looking for a GRA CMC Lead for Small Molecules and Complex Non-Biologic Drug Products to join us at our office in Zurich or St. Gallen. In this position, you will be directly reporting to the Head GRA CMC. We are offering a flexible and hybrid working model (#LI-Hybrid).

Position Purpose:

• The GRA CMC Lead provides tactical and strategic regulatory leadership and global oversight for all CMC regulatory aspects related to small molecules and complex non-biologics.

• The GRA CMC Lead is the subject matter expert for small molecules and complex non-biologics and the primary regulatory interface to relevant global technical expert functions. He/she oversees and interprets relevant existing or new regulatory requirements, evaluates draft guidelines, writes impact assessments, leads gap analysis and proposes solutions and strategies to remediate risks.

• The GRA CMC Lead provides complete, accurate and timely regulatory CMC strategies, submissions, advice, impact assessments and risk mitigation proposals to enable successful regulatory outcomes and facilitate balancing of business objectives and current health authority expectations.

• The GRA CMC Lead provides effective communications between Regulatory Affairs CMC and relevant stakeholders within GRA as well as across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones and deliverables according to project plans, and by the level of stakeholder satisfaction with the support provided by the group.

Responsibilities:

• Manages large team with average complexity that can include multiple teams led by Managers and/or Supervisors

• Focus on tactical and operational plans with short-to mid-term focus (e.g., 1-2 years)

• Problems faced are often complex and require extensive investigation and analysis

• Requires ability to influence others to accept practices and approaches, and ability to communicate outside own functional areas

• Oversees and directs regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies.

• Develops and implements regulatory product strategies.

• Establishes team priorities, goals and objectives while monitoring development and execution of tactical work plans to accomplish goals and objectives.

• Coordinates intracompany activities to obtain and compile information for submission to Regulatory Agencies regarding licenses and registrations.

• Interfaces directly with Regulatory bodies worldwide in obtaining product registration/licensure.

• Implements programs and procedures necessary to achieve compliance with new regulatory requirements.

• Develops consistent roles and work processes across the team, fostering adoption of technology to further improve consistency and efficiency of overall team.

• Develops and maintains good working relationships with all stakeholders.

• Maintains an intimate knowledge of relevant CMC regulations

• Provide strategic vision, leadership, expertise and oversight in all CMC regulatory aspects and activities for CSL’s small molecule and complex non-biologic drug product product portfolio, including driving Non-Biologics Complex Drug  Product’s principles within and outside the organization, with main focus on CMC activities.

Your Profile

• Advanced degree in a Life Science or Business (Master, PhD, MBA)

• 10+ years regulatory experience in the pharmaceutical industry, Regulatory experience preferred

• Demonstrated familiarity with and ability to interpret the Code of Federal Regulations and other FDA, EU, CA, AU and ICH documents to prepare regulatory / product development strategies

• At least 5 years leadership experience

• Fluent English and good level of German

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

For more information, please visit viforpharma.com

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