Manager Regulatory CMC Sciences (Injectables)

About Viatris

Viatris is a leading global healthcare organization combining the strengths of generics and branded medicines to comprehensively serve healthcare needs worldwide. With a mission to enable healthier lives at every life stage, Viatris supplies high-quality medication to nearly 1 billion patients annually across various therapeutic areas. Their broad portfolio includes iconic brand-name products, generics including complex and branded, and other healthcare solutions. Viatris fosters a collaborative and courageous workplace culture aimed at empowering employees to make a meaningful global impact.

Key Responsibilities

• Design and execute global Chemistry, Manufacturing and Controls (CMC) regulatory approaches specifically for injectable drug products.
• Interpret regulatory guidelines and provide risk-based advice to relevant teams to ensure compliance and strategic alignment.
• Prepare, evaluate, and analyze global CMC submission documents and manage lifecycle regulatory activities.
• Assist manufacturing facilities by developing suitable regulatory strategies and document preparation related to product variations and supplements.
• Maintain regulatory compliance through diligent oversight of CMC processes and change control management.
• Collaborate cross-functionally with regulatory, labeling, quality assurance, supply chain, and manufacturing departments to support regulatory submissions and interactions with agencies.
• Address inquiries from health authorities, participate in regulatory agency meetings and inspections.
• Serve as a subject matter expert on regulatory matters in cross-functional projects and mentor team members to enhance knowledge sharing and skill development.
• Stay updated on new regulatory requirements and industry trends, informing internal stakeholders of any potential impacts.

Skills, Qualifications, and Experience

• Bachelor's degree or equivalent in a scientific field.
• Proven regulatory affairs experience in the pharmaceutical sector.
• Direct experience authoring post-approval CMC submissions and lifecycle management.
• Specialized regulatory CMC knowledge related to injectable pharmaceutical products.
• In-depth understanding of global regulatory frameworks, with emphasis on US requirements.
• Experience with submissions for injectable, parenteral, or combination products.
• Strong written and oral communication capabilities including regulatory document preparation and review.
• Thorough knowledge of current Good Manufacturing Practice (cGMP) regulations, Code of Federal Regulations (CFR), United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and FDA guidance documents.
• Collaborative experience working with diverse functions such as Regulatory Affairs, Manufacturing, Supply Chain, Quality, Commercial, Medical, and Legal teams.
• Proficiency in Microsoft Office and regulatory compliance tools like TrackWise and Documentum.
• Effective project management skills ensuring delivery within agreed timelines, budgets, and quality guidelines.
• Previous experience managing people is advantageous.
• Professional certifications such as TOPRA or Regulatory Affairs Certification (RAC) are preferred.

Additional Information

Viatris values diversity and inclusion and encourages candidates who may not meet every requirement to apply, recognizing the broad range of talents that contribute to their mission. The company offers competitive salary packages, career growth opportunities, work-life balance initiatives, bonus schemes, health insurance, and pension benefits.

Committed to sustainability and corporate social responsibility, Viatris seeks to positively impact communities globally through responsible practices and empowerment.

As an Equal Opportunity Employer, Viatris fosters an inclusive environment where all employees can thrive and contribute meaningfully.