Biosimilars Regulatory Affairs Senior Manager

As the Biosimilars Regulatory Affairs Manager you will be responsible for defining and aligning all regulatory activities related to biosimilars for development, initial MAA/BLA registrations, and post-approval life cycle management at Zentiva. You will lead the development and execution of global regulatory strategies in close collaboration with co-development partners and internal and external stakeholders. Acting as regulatory lead for complex projects, you will draw upon broad regulatory and technical expertise to provide well-informed guidance across the organization. You will contribute to cross-functional planning and decision-making, ensuring alignment with global regulatory expectations and driving the successful delivery of Zentiva’s biosimilar strategy. In this role you will:

Responsibilities

• Ensure that all project activities comply with regulatory requirements and industry standards.
• Stay updated on changes in regulatory policies and guidelines related to biosimilars.
• Oversee the development, validation, and execution of physico-chemical, immunochemical, and biological methods for Zentiva’s biologics pipeline.
• Support the implementation of integrated analytical control strategies and systems that enable CMC development of biologic therapeutics, including process development, product characterization, and drug delivery from research through to product launch.
• Ensure GMP lot release, stability, and in-process testing for all clinical products globally, including effective deviation handling.
• Ensure effective and efficient transfer of methods to internal and external manufacturing sites as appropriate.
• Establish phase-appropriate comparability strategies in partnership with non-clinical, clinical, PK/PD, and process and product development teams.

Qualifications

• A master’s degree in Medicine, Pharmacy, Biotechnology or a related field, with at least 10 years of Regulatory Affairs experience in a biotech environment and a proven track record in biosimilars, including strong Regulatory/CMC expertise and analytical comparability exercises.
• Experience with biological products, preferably monoclonal antibodies (mAbs); experience with microbially expressed proteins is of advantage.
• Proven track record in managing international regulatory submissions including BLA/MAA filings and life cycle management variations.
• Experience in direct interactions with regulatory agencies, including biosimilars Scientific Advice with EMA and/or MHRA and US FDA.
• In-depth knowledge of biosimilar development processes covering regulatory requirements, analytics, drug substance and drug product development and manufacturing, clinical trials, and device development.
• Expert understanding of global regulatory frameworks, with a focus on EMA, UK MHRA, and US FDA, and experience with requirements in emerging markets such as India, China, South Korea, and Brazil considered an advantage.
• Excellent organizational, planning, and communication skills, with the ability to work effectively in matrixed, cross-functional, and intercultural co-development alliances.
• Fluency in English and willingness to travel up to 25%.

Company Culture

Diversity is a fact. Inclusion is an act @Zentiva At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with variouseducational and industry experiences,cultural or ethnical backgrounds, and differentlife experiencesorabilities,regardless of theirreligious or philosophical beliefsorwhomever they choose to love. Join our winning team! Be a part of our winning culture! Be Zentiva! At Zentiva, we provide health and wellbeing for all generations, with focus on developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 40 countries across Europe. We have four manufacturing sites and a broad network of external manufacturing partners. Zentiva employs more than 5,400 unique talents in over 30 countries, bonded together by a commitment to the people who depend on our products every day.