Regulatory Manager

Job Summary:
The Regulatory Manager will support and execute the planning, preparation, and submission of regulatory documents to global health authorities. In this role, you will support regulatory project planning, timelines, communications, and ensure successful regulatory submissions and deliverables on time. You will help maintain the internal systems and processes that enable efficient regulatory execution. This position is ideal for someone who thrives in a fast-paced, collaborative biotech environment and wants to contribute directly to bringing innovative therapies to patients.

Key Responsibilities:

• Manage submission timelines and coordinate document deadlines across Regulatory, Clinical, CMC, Nonclinical, and Quality functions

• Prepare, review, format, and publish high quality regulatory documents (e.g., IND/CTA, amendments, DSURs, meeting packages, eCTD modules) for FDA and other global regulatory agencies

• Manage project communication and stakeholder expectations, providing transparent status updates and risk identification

• Experience or familiarity with eCTD publishing systems and document management platforms (e.g., Veeva Vault, Egnyte, SharePoint)

• Conduct technical quality checks, bookmarking, hyperlinking, and ensuring compliance with eCTD and regional requirements

• Maintain submission archives and lifecycle management in accordance with regulatory guidance and internal SOPs

• Track agency correspondence and commitments; assist in preparing responses to health authority requests

• Support development and continuous improvement of regulatory processes, templates, and standards

• Assist with regulatory intelligence monitoring

• Support regulatory authority interactions

• Contribute to inspection readiness and support regulatory audits, as needed

Requirements:
• Bachelor's or higher degree in a scientific discipline

• Minimum of 5 years of experience in regulatory operations, regulatory affairs, or eCTD publishing within the biotech/pharmaceutical industry

• Strong attention to detail, organizational skills, and ability to manage multiple tasks under tight timelines

• Excellent written and verbal communication and interpersonal skills

• Experience in a small or early-stage biotech environment

• Strong knowledge of global investigational submission standards and processes (eCTD, FDA/EMA requirements, ICH guidelines)

• Familiarity with regulatory publishing tools (e.g., Lorenz DocuBridge, Veeva RIM, GlobalSubmit, eCTDmanager) and document management systems

• Team player, with the ability to develop collaborative relationships in an often remote online team environment

Benefits:
We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $138,000- $148,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including:

• 90% employer-covered benefits

• Flexible PTO

• A very generous holiday schedule that includes a week off in August and time off around the winter holidays

• A well-stocked kitchen with snacks and beverages

• Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.

• The comprehensive wellness program includes medical, dental, vision, and LTD coverage.