Alvotech is looking for a Regulatory Support Lead to join our MSAT (Manufacturing Science and Technology) department. This position serves as the primary liaison between Manufacturing and Regulatory functions, ensuring seamless coordination and adherence to global regulatory standards, including EMA, FDA, and RoW markets.
Scope & Responsibilities:
- Lead author dossiers sections related to manufacturing processes and controls for drug substance and drug product regulatory filings.
- Provide CMC support for regulatory submissions, ensuring GMP compliance.
- Collaborate with cross-functional teams, including PharmSci and development teams, to co-author critical dossier sections.
- Review and refine dossier sections related to DS and DP manufacturing and timely support towards the product approval process.
- Support in submission of response related to deficiency letters received from health authority and update the dossier sections related to response.
- Involve in Life cycle management of commercialized Biosimilar products and support process changes and provide regulatory impact.
- Ensure dossier content aligns with approved manufacturing source documents and facilitate necessary corrections.
- Contribute to health authority audits by providing critical information to the MSAT team.
- Represent MSAT in all regulatory discussions concerning dossier submissions and compliance requirements.
Job Requirements:
- MBA in International Business and Bachelor of Technology in Biotechnology or a related field.
- 10+ years of experience in Biopharmaceutical Regulatory Affairs and Biosimilar Manufacturing.
- Expertise and knowledge of monoclonal antibodies manufacturing (DS and DP)
- Knowledge of updated regulatory guidelines and GMP guidelines Strong communication and cross-functional collaboration skills.
- Ability to evaluate, anticipate, and resolve technical challenges.
- Experience in process validation strategy and compliance with regulatory filing requirements.
- Attention to detail, adherence to SOPs, PDDs, and documentation impacting regulatory dossiers.
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What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Internet at home for full-time employees.
Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.