Are you a skilled Technical Writer with a passion for science and a knack for transforming complex data into clear, regulatory-ready documentation? Alvotech, a global leader in biosimilars, is looking for a talented individual to join our dynamic team in India. This is your chance to play a pivotal role in developing affordable biologic medicines that impact millions of lives worldwide.
If you have experience in pharmaceutical regulatory writing, particularly with Module 3 CMC dossiers, and thrive in a collaborative, international environment, we want to hear from you.
About Alvotech
Alvotech is a multinational biopharmaceutical company focused solely on the development and manufacture of biosimilars. Our mission is to increase global access to critical biologic therapies by creating high-quality, more affordable alternatives.
True to our Icelandic roots, we operate with integrity, fairness, and a deep commitment to innovation. We pride ourselves on our inclusive, diverse, and purpose-driven culture that encourages curiosity, ingenuity, and simplicity. By joining Alvotech, you become part of a fast-growing company dedicated to creating a healthier world.
Job Description: Technical Writer
As a Technical Writer at Alvotech, you will be at the heart of our regulatory submission process. You will collaborate with cross-functional scientific teams to create the comprehensive documentation required for successful health authority interactions and approvals.
Key Responsibilities:
- Prepare Regulatory and Technical Documentation: Develop a wide range of critical documents, including:
- Briefing books for health authority meetings (e.g., US FDA, EMA).
- Module 3 (Quality) sections of regulatory dossiers (CTD).
- Critical quality assessments and risk ranking reports.
- Protocols and reports for process development, validation, and analytical methods.
- Collaborate Across Teams: Work closely with internal stakeholders and Subject Matter Experts (SMEs) from Pharmaceutical Sciences, Quality Control, Manufacturing, Regulatory Affairs, and Program Management to gather and synthesize necessary information.
- Content Development and Editing: Research, structure, write, and revise both new and existing documentation to ensure accuracy, clarity, and alignment with regulatory expectations.
- Template Management: Apply and maintain document templates to ensure consistency and efficiency across all projects.
- Dossier Translation: Expertly convert complex scientific source materials into high-quality, submission-ready dossier content.
Qualifications Required:
- Education: BSc in a scientific subject, preferably Biotechnology, Biochemistry, or a related field.
- Experience:
- Proven experience in technical report writing within a scientific setting.
- Experience in regulatory document writing (Module 3 CMC) is highly desired and a significant advantage.
- A strong scientific background with experience in data gathering, summarization, and evaluation.
- Technical Skills:
- High proficiency in Microsoft Word and Excel (including figure generation).
- Knowledge of Prism (GraphPad) and JMP is a strong plus.
- An understanding of antibody/protein structure and familiarity with protein manufacturing processes (e.g., cell line development, upstream/downstream processing, drug product development, analytics) is highly beneficial.
- Soft Skills:
- Excellent written and verbal communication skills.
- Ability to work independently and cross-functionally with various departments.
- Strong multitasking skills to manage several projects simultaneously under deadline.
- A flexible, can-do attitude and a commitment to quality.
What We Offer:
Joining Alvotech means more than just a job; it’s an opportunity to grow and make a difference. We offer:
- Impactful Work: Contribute to ambitious projects that change patients’ lives by increasing access to affordable biologics.
- Global Opportunities: Be part of a fast-growing global company with a clear organizational structure and opportunities for advancement and training.
- Inclusive Culture: Work in a positive, flexible, and innovative environment that encourages diversity, collaboration, and inclusion.
- Work-Life Balance: We value your well-being and offer a positive work culture that supports balance.
- Home Office Support: Provision for home internet and home office equipment to ensure you are set up for success.
How to Apply
Ready to inspire your career and take on this inspiring challenge?
The application deadline is September 25, 2025.
Location: India (Full-time)
Application Deadline: September 25, 2025
