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

 

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 ma