Regulatory Writer

Global Organization Seeking High Level Regulatory Writer with AI Experience Make your application after reading the following skill and qualification requirements for this position. This Jobot Job is hosted by: Amanda Cohen Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $180,000 - $240,000 per year 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. Interested in hearing more? Easy Apply now by clicking the "Apply Now" button. 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, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. 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. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. xrczosw You can reply STOP to cancel and HELP for help. You can access our privacy policy here: /privacy-policy