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Regulatory Writer
1 month ago
**Overview of role**
The Regulatory Writer will work with a cross-functional team to author documents independently or as part of a team. The writer will proactively coordinate with stakeholders to build content. Importantly, the writer will deliver accurate documents with clear messaging according to the timeline. The writer is responsible for the final deliverable.
The writer must understand clinical trial design and interpretation of statistically analyzed clinical research data, as well as regulatory implications for dossier writing (e.g., eCTD module 2 nonclinical/clinical).
The Regulatory Writer will drive and coordinate the process to draft, review, and approve written assignments. They need to meet the quality standards of the global organization.
**Scope and responsibility**:
- Authors a range of clinical/nonclinical regulatory documents using templates, including
- but not limited to
- BLA/MAA eCTD submission documents (focusing on 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 with the SME and within the global team. Promotes high regulatory writing standards by pointing out flaws and proposing 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 greater
- 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 biotechnology-derived 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 co-workers on ambitious projects that change people's lives.
- The chance to be part of a global and fast-growing 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 work-life 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.
