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We are seeking a Clinical Regulatory Affairs Manager to support global regulatory activities for a growing biopharmaceutical organization developing novel therapies. This role will play a key part in preparing and coordinating regulatory submissions, including INDs, CTAs, NDAs, and briefing packages, while ensuring alignment with global regulatory requirements and organizational objectives.
Key Responsibilities
Support the development and execution of global regulatory strategies throughout the product lifecycle, from early development through registration and post-approval maintenance.
Prepare, review, and coordinate high-quality regulatory submissions (e.g., INDs, NDAs, amendments, supplements, CTAs, briefing materials, meeting packages).
Collaborate cross-functionally with clinical, nonclinical, CMC, and operations teams to manage submission deliverables and timelines.
Review regulatory documents for accuracy, consistency, and compliance with relevant regional requirements.
Assist in authoring responses to regulatory authority inquiries and information requests.
Contribute to planning and coordination of meetings with U.S. and international health authorities.
Stay informed of current and emerging regulatory guidelines, policies, and best practices.
Partner with Regulatory Operations to ensure all submissions meet formatting, quality, and archival standards.
Participate in continuous improvement initiatives related to regulatory processes, templates, and standard operating procedures.
Qualifications
Bachelor’s degree in Life Sciences or a related discipline required; a Master’s in Regulatory Affairs or related field preferred.
5–8 years of regulatory affairs experience within the pharmaceutical or biotechnology industry.
Demonstrated experience supporting IND and NDA preparation and submissions.
Strong understanding of FDA and ICH guidelines, and familiarity with eCTD format and module requirements (M1–M5).
Exceptional attention to detail, organizational skills, and written communication abilities.
Proficiency with Microsoft Word, Adobe Acrobat Pro, and document management systems.
Ability to effectively manage multiple priorities in a fast-paced, deadline-driven environment.
Preferred Experience
Direct involvement in NDA or marketing application preparation and submission.
Experience with small molecules, biologics, or combination products.
Exposure to ex‑U.S. clinical trial applications and related regulatory processes.
Familiarity with Regulatory Information Management (RIM) systems or other electronic submission platforms.
Locations and salary ranges: Charlton, MA: $90,000.00–$110,000.00 Boston, MA: $160,000.00–$240,000.00
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Key Responsibilities
Support the development and execution of global regulatory strategies throughout the product lifecycle, from early development through registration and post-approval maintenance.
Prepare, review, and coordinate high-quality regulatory submissions (e.g., INDs, NDAs, amendments, supplements, CTAs, briefing materials, meeting packages).
Collaborate cross-functionally with clinical, nonclinical, CMC, and operations teams to manage submission deliverables and timelines.
Review regulatory documents for accuracy, consistency, and compliance with relevant regional requirements.
Assist in authoring responses to regulatory authority inquiries and information requests.
Contribute to planning and coordination of meetings with U.S. and international health authorities.
Stay informed of current and emerging regulatory guidelines, policies, and best practices.
Partner with Regulatory Operations to ensure all submissions meet formatting, quality, and archival standards.
Participate in continuous improvement initiatives related to regulatory processes, templates, and standard operating procedures.
Qualifications
Bachelor’s degree in Life Sciences or a related discipline required; a Master’s in Regulatory Affairs or related field preferred.
5–8 years of regulatory affairs experience within the pharmaceutical or biotechnology industry.
Demonstrated experience supporting IND and NDA preparation and submissions.
Strong understanding of FDA and ICH guidelines, and familiarity with eCTD format and module requirements (M1–M5).
Exceptional attention to detail, organizational skills, and written communication abilities.
Proficiency with Microsoft Word, Adobe Acrobat Pro, and document management systems.
Ability to effectively manage multiple priorities in a fast-paced, deadline-driven environment.
Preferred Experience
Direct involvement in NDA or marketing application preparation and submission.
Experience with small molecules, biologics, or combination products.
Exposure to ex‑U.S. clinical trial applications and related regulatory processes.
Familiarity with Regulatory Information Management (RIM) systems or other electronic submission platforms.
Locations and salary ranges: Charlton, MA: $90,000.00–$110,000.00 Boston, MA: $160,000.00–$240,000.00
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