Director/Senior Director Regulatory Affairs & Medical Writing

Job Title: Sr./Director Regulatory Affairs and Medical Writing Company: Recludix Pharma, Inc Location: San Diego, CA or Cambridge, MA Recludix Pharma is a venture capital-funded biotechnology company located in San Diego, California and Cambridge, Massachusetts. We are engaged in small molecule drug discovery for the treatment of targeted patient populations in autoimmune disease and oncology. Recludix Pharma is looking for experienced candidates who desire to work in a dynamic early-stage startup environment as a member of our San Diego team. Job Summary: We are seeking an experienced Regulatory leader to help guide our small molecule portfolio in inflammation and oncology through IND and clinical development. A successful candidate will have a relevant track record of managing IND submissions and navigating assets through the complex regulatory environment. The successful candidate will define a cohesive regulatory strategy and manage our portfolio as it continues to advance into the clinic. Responsibilities: Regulatory Affairs and Compliance: • Develop and execute regulatory strategies in alignment with company goals. • Serve as the primary liaison with regulatory agencies (FDA, EMA, etc.) to facilitate effective communication and timely submission of applications. • Stay current with evolving regulatory guidelines and industry standards to ensure compliance. • Ensure that all regulatory activities adhere to relevant guidelines, laws, and regulations. • Prepare and submit regulatory filings, including (IND/CTA/MAA /NDA) applications, amendments, and annual reports. • Support regulatory inspections and audits as needed. • Regulatory affairs project management - manage and coordinate cross-functional project teams to meet submission milestones and deadlines for IND/CTA/MAA /NDA applications Medical Writing: • Lead and oversee the development of high-quality regulatory documents, including IND submissions, clinical trial protocols, investigator brochures, and safety reports. • Ensure all medical writing materials are scientifically accurate, well-organized, and compliant with regulatory requirements. • Collaborate closely with cross-functional teams to gather necessary data and insights for regulatory documents. Qualifications: • Bachelor’s degree in a relevant scientific field; advanced degree (M.S. or Ph.D, or equivalent) preferred. • Minimum of 8 years of experience in regulatory affairs within the biotechnology or pharmaceutical industry. • Strong expertise in regulatory and medical writing, including the development of IND submissions and other regulatory documents. • Proven track record of successful IND submissions and regulatory approvals. • Project management experience, including the ability to lead cross-functional teams and manage complex timelines. • Excellent communication and interpersonal skills. • Familiarity with inflammatory/autoimmune disease and oncology is a plus. • Regulatory certifications (e.g., RAC) are desirable. Further Information: Salary range: $190,000 to $250,000 (See Below) In addition to a competitive compensation package with stock options, Recludix Pharma also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life insurance, disability insurance and a 401(k) plan. Recludix Pharma is proud to be an Equal Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Recludix Pharma is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at resumes@recludix.com. Recludix Pharma requires that all employees be fully vaccinated against COVID-19 and provide proof thereof, or receive an approved medical or religious exemption. To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to resumes@recludix.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions