Senior Manager Global Regulatory Affairs CMC

CSL; Schweiz; On-site; CHF 160,000 - 210,000; Full time

Job summary

CSL is seeking a Regulatory Affairs leader to define global CMC strategies for biological and non-biol products, partnering with R&D, Manufacturing, Quality, and Regulatory Affairs to ensure compliant lifecycle management.

You will author and review regulatory submissions, manage change controls, and maintain strong regulator relationships to support timely approvals and market access across regions.

Qualifications

• Bachelor's degree in biological or chemical sciences or related field is required.
• Advanced degree (MS/PhD) strongly preferred.
• 5+ years of progressive regulatory experience in biologics/plasma.

Responsibilities

• Lead global regulatory CMC strategy across development and commercial portfolios.
• Manage development and submission of regulatory submissions and components.
• Ensure timely change control assessments within CSL's quality system.
• Leverage external insights to refine regulatory strategies and approaches.
• Represent CSL in official regulatory CMC interactions and maintain regulator relationships.
• Develop strategic plans for Global Regulatory Affairs CMC and advise leadership.
• Provide regulatory consultation across Global Operations, R&D, IT and other functions.
• Contribute to contingency planning and issue resolution while complying with regulations.

Skills

Regulatory strategy

CMC knowledge

Regulatory submissions

Change control

Cross-functional leadership

Stakeholder management

Education

Bachelor's degree in biological or chemical sciences

Advanced degree (MS, PhD) preferred

Job description

Partnering closely with CSL's R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio.

Defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL's biological & non-biol. products.

Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies.

This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL's strategic business objectives.

Main Responsibilities and Accountabilities

• Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.
• Manage the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including new marketing applications, clinical trial applications, variations/supplements, periodic compliance reports and renewals. Ensure timely execution aligned with regulatory expectations and business goals.
• Ensure accurate and timely change control assessments of change control notifications in CSL's quality management system for biological & non-biol. product-related change controls. This includes the country-specific reporting category and detailed submission documentation requirements.
• Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL's competitive positioning for its biological & non-biol. product portfolio.
• Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies. Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests. Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management.
• Develop strategic and tactical plans for Global Regulatory Affairs CMC, advising Global Regulatory Affairs CMC leadership and CSL stakeholders on regulatory requirements and their implications for project timelines, compliance, and business strategy. Contribute to the evaluation of new business opportunities in collaboration with development teams.
• Provide regulatory consultation to internal CSL functions, including Global Operation functions, R&D, and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence.
• Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.
• Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company's regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
• Ensure regulatory policies and procedures are developed and implemented in accordance with applicable international standards and requirements.
• Support the creation and execution of regulatory policies, processes, and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness across Global Operations and its stakeholder network.
• Support the outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements.

Position Qualifications and Experience Requirements

Education & Experience

• A bachelor's degree in biological or chemical sciences, or a related field is required; an advanced degree (e.g., MS, PhD) is strongly preferred.
• Over 5 years of progressive experience in regulatory roles within the biologics or plasma industry, demonstrating increasing levels of responsibility.
• Strong technical foundation with in-depth knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and life-cycle management.
• Proven expertise in authoring, reviewing, and managing regulatory submissions ensuring accuracy, compliance, and timely delivery.
• Demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeh