Regulatory Writer - Pharma - Global Company
Use our easy apply form to send your application to Amanda Cohen, the Jobot Pro hosting this job. Compensation Based on Experience. Regulatory Writer - Pharma - Global Company $180000 - $240000 per year | Boston, MA | Remote | Permanent Global Organization Seeking High Level Regulatory Writer with AI Experience A bit about us: We are a global, innovative company in the biotech and pharmaceutical sector, focused on supporting the development of life-changing therapies. Our collaborative and inclusive culture allows team members to grow professionally while making meaningful contributions to the regulatory landscape. Why join us? Work with a team of experts on diverse projects across therapeutic areas. Engage in meaningful work that directly supports regulatory approvals and patient outcomes. Opportunity for professional growth and development in a supportive environment. Exposure to cutting-edge biotech and pharmaceutical practices without being tied to a single therapy or company. Job Details We are seeking a Regulatory Writer to join our team to develop high-quality documentation that supports regulatory submissions. This role is ideal for someone with experience in nonclinical and submission-level documents who is looking to work in a dynamic, project-focused environment. Responsibilities Collaborate with internal teams, partners, and clients to develop strategies for organizing and preparing regulatory documents. Lead or contribute to the creation of nonclinical and submission-level documents in alignment with regulatory authority guidelines. Manage document review processes, including comment resolution and team coordination. Provide guidance and coaching to junior staff on document preparation and regulatory requirements. Support project delivery, ensuring clarity, accuracy, and adherence to timelines and quality standards. Qualifications Bachelor’s degree required; advanced degree preferred (MS/PhD in a relevant field). 8+ years of regulatory writing experience or equivalent, Experience authoring submission-level documents, understanding regulatory authority expectations. Skills & Abilities Intermediate to advanced Microsoft Word and document management proficiency. Strong understanding of the regulatory submission lifecycle. Ability to synthesize data from multiple sources into clear, concise, and accurate documents. Excellent communication, problem-solving, and project management skills. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Apply tot his job