Celldex
Join to apply for the
Regulatory Affairs Manager
role at
Celldex Join to apply for the
Regulatory Affairs Manager
role at
Celldex Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory and autoimmune disorders. As our pipeline progresses toward major regulatory milestones, we are seeking a highly motivated Regulatory Affairs Manager to join our growing Regulatory Affairs team.
This role is essential to supporting the increasing volume of regulatory activities and will serve as a key partner on clinical study teams and cross-functional working groups. With a U.S. focused scope, the Regulatory Affairs Manager will contribute to the development and execution of regulatory strategies, the preparation of high-quality submission packages, and the operational coordination of key deliverables in collaboration with the broader Regulatory Affairs team.
Responsibilities
Support the planning, coordination, and execution of regulatory submissions, including INDs, amendments, annual reports, and other regulatory documentation for U.S. programs Serve as a Regulatory Affairs representative on clinical study teams and cross-functional project teams, ensuring alignment and timely delivery of regulatory deliverables Assist in authoring, reviewing, and compiling high-quality submission packages in accordance with FDA and ICH guidelines Interpret scientific data and study results to support the development of clear, concise regulatory documents Collaborate cross-functionally with Clinical Development, CMC, Quality, Program Management, and external partners to track and meet regulatory timelines Maintain up-to-date knowledge of U.S. regulatory requirements, guidance, and industry best practices Ensure submission content complies with applicable regulations, standards, and internal quality expectations Contribute to internal process improvements and department best practices to ensure operational excellence
Qualifications
Bachelors degree in Life Sciences, Biotechnology, Pharmacy, or a related field is required; advanced degree is a plus 46 years of experience in drug development, with at least 2 years in Regulatory Affairs preferred Prior involvement in cross-functional clinical development teams; experience with regulatory submissions (INDs, amendments) is highly desirable Strong understanding of U.S. regulatory frameworks and familiarity with FDA 21 CFR, ICH, and EMA guidelines Excellent project management and communication skills; ability to manage multiple priorities effectively and adapt to shifting timelines Demonstrated ability to interpret complex scientific data and translate it into regulatory language Self-motivated, organized, and detail-oriented with a proactive and solution-oriented mindset Proficient in Microsoft Office and regulatory documentation tools
Compensation
The expected base salary range for this position is $126,000 to $141,000.
We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
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Regulatory Affairs Manager
role at
Celldex Join to apply for the
Regulatory Affairs Manager
role at
Celldex Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory and autoimmune disorders. As our pipeline progresses toward major regulatory milestones, we are seeking a highly motivated Regulatory Affairs Manager to join our growing Regulatory Affairs team.
This role is essential to supporting the increasing volume of regulatory activities and will serve as a key partner on clinical study teams and cross-functional working groups. With a U.S. focused scope, the Regulatory Affairs Manager will contribute to the development and execution of regulatory strategies, the preparation of high-quality submission packages, and the operational coordination of key deliverables in collaboration with the broader Regulatory Affairs team.
Responsibilities
Support the planning, coordination, and execution of regulatory submissions, including INDs, amendments, annual reports, and other regulatory documentation for U.S. programs Serve as a Regulatory Affairs representative on clinical study teams and cross-functional project teams, ensuring alignment and timely delivery of regulatory deliverables Assist in authoring, reviewing, and compiling high-quality submission packages in accordance with FDA and ICH guidelines Interpret scientific data and study results to support the development of clear, concise regulatory documents Collaborate cross-functionally with Clinical Development, CMC, Quality, Program Management, and external partners to track and meet regulatory timelines Maintain up-to-date knowledge of U.S. regulatory requirements, guidance, and industry best practices Ensure submission content complies with applicable regulations, standards, and internal quality expectations Contribute to internal process improvements and department best practices to ensure operational excellence
Qualifications
Bachelors degree in Life Sciences, Biotechnology, Pharmacy, or a related field is required; advanced degree is a plus 46 years of experience in drug development, with at least 2 years in Regulatory Affairs preferred Prior involvement in cross-functional clinical development teams; experience with regulatory submissions (INDs, amendments) is highly desirable Strong understanding of U.S. regulatory frameworks and familiarity with FDA 21 CFR, ICH, and EMA guidelines Excellent project management and communication skills; ability to manage multiple priorities effectively and adapt to shifting timelines Demonstrated ability to interpret complex scientific data and translate it into regulatory language Self-motivated, organized, and detail-oriented with a proactive and solution-oriented mindset Proficient in Microsoft Office and regulatory documentation tools
Compensation
The expected base salary range for this position is $126,000 to $141,000.
We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Legal Referrals increase your chances of interviewing at Celldex by 2x Sign in to set job alerts for Regulatory Affairs Manager roles.
New Haven, CT $62,200.00-$91,900.00 1 day ago Connecticut, United States $200,000.00-$325,000.00 4 days ago Connecticut, United States $62,000.00-$86,000.00 2 days ago Quality Assurance Manager - Behavioral Health
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr