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Senior Regulatory Submission Manager (IND/NDA/BLA/MAA)

Horsham, Pennsylvania, United States

 

Location: Horsham, PA (HYBRID)

Schedule: Permanent- FTE

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Regulatory Submissions Manager in HYBRID model at Horsham, PA on a permanent basis, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device, and consumer health companies.

 

We are looking for Candidates with 8-10 years of experience in regulatory affairs in pharma/CRO and will lead regulatory submission strategy, authoring, coordination, and delivery for global pharmaceutical clients within a CRO environment.

 

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

 

Position Overview


The Senior Regulatory Submission Manager will lead regulatory submission strategy, authoring, coordination, and delivery for global pharmaceutical clients within a CRO environment. This role requires extensive hands-on expertise in regulatory submissions and authoring, combined with strong leadership and client-facing skills. The successful candidate will work with our Global team to oversee submissions while contributing to proposal development (RFPs) and supporting business growth. The successful candidate will serve as both a subject matter expert and a trusted advisor to clients, providing strategic oversight while ensuring operational excellence in submission execution. 

Key Responsibilities

•    Lead the planning, authoring, review, and submission of global regulatory filings on behalf of clients, including INDs, NDAs, BLAs, MAAs, CTAs, variations, supplements, amendments, renewals, annual reports, and health authority responses.
•    Serve as a principal author for critical submission components ensuring scientific accuracy, clarity, and alignment with regulatory expectations.
•    Oversee and provide strategic direction for life cycle management (LCM) submissions, including labeling updates, safety reports, variations, and other post-approval activities.
•    Partner with clients to define submission strategies, anticipate regulatory challenges, and ensure deliverables align with program goals and timelines.
•    Provide oversight, guidance, and quality review for documents authored by cross-functional contributors, junior regulatory staff, and subject matter experts.
•    Act as a client-facing leader, ensuring effective communication, issue resolution, and alignment of regulatory deliverables with client expectations.
•    Support business development teams by contributing to RFPs, developing submission strategies for proposals, and scoping deliverables, timelines, and costs.
•    Ensure all submissions comply with FDA, EMA, ICH, and regional health authority requirements, as well as eCTD standards and internal SOPs.
•    Collaborate with publishing teams to ensure timely, accurate, and compliant electronic submissions.
•    Drive continuous process improvements, knowledge sharing, and development of best practices within the regulatory submissions group.
•    Mentor and guide junior team members, providing professional development support and fostering a high-performance culture.

Qualifications

•    Bachelor’s degree in Life Sciences, Pharmacy, or related field (advanced degree preferred).
•    8–10+ years of regulatory submission experience within the pharmaceutical or CRO industry, including leadership responsibilities.
•    Proven expertise in authoring and managing global submissions, including initial marketing applications (NDA, BLA, MAA) and life cycle management submissions (supplements, variations, renewals, labeling updates).
•    Experience with unique submission types such as Pediatric Investigation Plans (PIPs), Orphan Drug Designation (ODD) applications, and expedited regulatory pathways (e.g., Fast Track, Breakthrough Therapy).
•    Strong knowledge of FDA, EMA, ICH, and global regulatory frameworks.
•    Demonstrated client-facing experience with the ability to build trusted relationships and provide strategic guidance.
•    Proficiency with eCTD publishing tools, regulatory information management (RIM) systems, and document management platforms.
•    Excellent organizational, project management, and communication skills, with the ability to manage multiple clients and projects simultaneously.

Preferred Skills
•    Prior CRO or consultancy experience with direct responsibility for client projects.
•    Experience contributing to RFPs, business development activities, and client proposals.
•    Prior direct interactions with health authorities on behalf of clients.
•    Experience mentoring or managing regulatory professionals in submission and authoring roles.

 

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

 

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

 

Key words: Regulatory Affairs, IND/NDA submissions, pharmaceuticals, CRO. 

#LI-PR1 #LI-Hybrid

 

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