Senior Manager, Regulatory Affairs CMC and Devices at Jobgether

, , United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jun, 26

Salary

0.0

Posted On

25 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, CMC Submissions, Device Submissions, IND Submissions, IMPDs, CTAs, Technical Authoring, Health Authority Interactions, Regulatory Compliance, Drug-Device Combination Products, Technical Operations Collaboration, Veeva RIM, eCTD Publishing, Technical Writing, Attention To Detail, Project Management

Industry

Internet Marketplace Platforms

Description

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager, Regulatory Affairs CMC and Devices in United States. This role offers a pivotal opportunity to lead regulatory strategy and execution for clinical-stage biologics and drug-device combination products. You will be responsible for preparing, authoring, and coordinating high-quality CMC and device-related submissions that enable clinical trial initiation and progression. Working closely with cross-functional teams, you will ensure compliance with global regulatory requirements while providing strategic input on regulatory plans. This is a hands-on position with direct influence on product development timelines and health authority interactions, offering exposure to complex regulatory challenges across multiple therapeutic candidates. The role requires meticulous attention to detail, exceptional technical communication skills, and the ability to thrive in a fast-paced, collaborative environment where your contributions have measurable impact on advancing clinical programs. \n Accountabilities: Plan, coordinate, and manage global CMC and device regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring compliance and high-quality documentation Independently author and compile Module 2 and Module 3 content, including quality summaries, drug substance and product data, stability information, comparability assessments, and supporting technical reports Prepare scientifically sound responses to CMC and device-related questions from global regulatory agencies, including FDA, EMA, PMDA, and other health authorities Contribute to regulatory strategy and documentation for drug-device combination products, including device technical files and integration into clinical submissions Collaborate closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions Execute CMC and device regulatory strategies in alignment with clinical development objectives and organizational goals Maintain accurate records and ensure timelines are met for multiple concurrent submissions Requirements: Bachelor’s degree with 5+ years of experience in CMC regulatory affairs supporting clinical-stage biologics programs (or equivalent combination of education and experience) Hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation Proven experience preparing responses to health authority questions related to CMC and drug-device combination products Strong knowledge of global CMC regulatory requirements and guidelines, including FDA, EMA, ICH, and applicable device regulations Experience with biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus Exceptional technical writing and communication skills, with the ability to convey complex technical information clearly Detail-oriented with strong organizational skills and the ability to manage multiple submissions and timelines simultaneously Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories) Ability to collaborate effectively with cross-functional teams in a fast-paced, dynamic environment Benefits: Market-competitive base salary with performance bonus and equity grant opportunities Health, welfare, and retirement benefits Unlimited paid time off (PTO) and two one-week company-wide shutdowns per year Remote working environment with occasional in-person meetings for collaboration Opportunities for professional development and career growth Dynamic, fast-paced environment contributing to meaningful medicines and innovative therapies Exposure to strategic regulatory work across multiple clinical-stage candidates \n Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1

Responsibilities

This role involves planning, coordinating, and managing global CMC and device regulatory submissions, including INDs and CTAs, while independently authoring and compiling Module 2 and Module 3 content. Responsibilities also include preparing scientifically sound responses to global regulatory agencies and contributing to regulatory strategy for drug-device combination products.