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Regulatory Writer

4 months ago

Bengaluru, Karnataka, India Alvotech Full time

Overview of role


The Regulatory Writer is expected to work on assignments largely independently or for complex documents facilitating the delivery of the written assignments through proactive coordination of stakeholders to build content.

The writer understands clinical trial design and interpretation of statistically analysed clinical research data as well as regulatory implications for dossier writing (e.g. eCTD module 2 nonclinical/clinical).


The Regulatory Writer would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization.

The writer is responsible for the final deliverable and is expected to work in complex matrix organizations.

Scope and responsibility:

  • Authors a range of regulatory documents with clinical scope following defined templates, including but not limited to BLA/MAA eCTD submission documents (with focus on, but not limited to eCTD module 2 nonclinical/clinical), briefing documents, and responses to regulatory authority questions.
  • Ensures high integrity of data interpretation, following negotiation with the team.
  • Ensures the consistency and quality level of all documents that are issued.
  • Actively participates in all planning, coordination and review meetings.
  • Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability to promote high medical/regulatory writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
  • Establishes a network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in the delivery of writing assignments.

Job requirements:

  • BSc degree or equivalent
  • 5+ years of clinical/regulatory writing experience in the pharmaceutical industry (authoring BLA/MAA/IND/BB)
  • Expertise in global dossier authoring for biologics/biosimilars (EMA/FDA) (preferred)
  • Possesses a good understanding of basic drug development of biotechnologyderived medicinal products.
  • Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
  • Demonstrates understanding of how to interpret, describe and document clinical/nonclinical data in the context of EMA and FDA regulatory framework.
  • Possesses working knowledge of the International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
  • Previous experience in projects with biosimilars would be of advantage.

What we offer:

  • Option to work hybrid.
  • An inspiring challenge to work with great coworkers on ambitious projects that change people's lives.
  • The chance to be part of a global and fastgrowing company.
  • An international work culture that encourages diversity, collaboration, and inclusion.
  • Positive, flexible, and innovative work environment.
  • A clear and developed organizational structure.
  • Training and global opportunities to advance.
  • A good worklife balance.
  • Home internet and home office equipment.

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.