Bengaluru, Karnataka, India · On-site
Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Support for the registration of OTC drugs in EU countries. Support regional R…
Skills: Regulatory Affairs, Submission Management, MRP & DCP Procedures, PSUSA Submission, OTC Drug Registration
Bengaluru, Karnataka, India · On-site
Responsibilities: Authoring regulatory submissions: Writing and reviewing the CMC sections for new e.g. New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) and lifecycle maintenance regulatory f…
Skills: CMC Authoring, Regulatory Submissions, Technical Writing, eCTD, ICH Guidelines
Bengaluru, Karnataka, India · On-site
Responsibilities: Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval Responsible for reviewing and writing CMC modules 2 an…
Skills: Regulatory Affairs, CMC Modules 2 and 3, Product Registration, Product Life Cycle Management, Regulatory Compliance
Brussels, Brussels-Capital, Belgium · On-site
Senior Specialist, Procurement Summary: The Senior Specialist, Procurement is responsible for optimizing procurement processes and managing supplier relationships across various sectors including engineering, production,…
Skills: Procurement, Supplier Relationship Management, Sourcing, Negotiation, Bid Analysis
United States · Hybrid
Job Description – Medical Writer / Medical Reviewer (Ovarian Cancer Oncology Expertise) Position Title Medical Writer / Medical Reviewer – Oncology (Ovarian Cancer) Location Remote / Hybrid Position Summary We are seekin…
Skills: Medical Writing, Medical Review, Ovarian Cancer Expertise, Clinical Study Reports, Protocol Development
United States · On-site
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice …
Skills: R Programming, SAS, SDTM, ADaM, CDISC Standards
Ontario, Canada · Hybrid
$1/hr–$2/hr
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Skills: Regulatory Affairs, Medical Device Regulations, Health Canada Compliance, EU MDR, ISO13485
Pasig, Metro Manila, Philippines · On-site
Responsibilities: Identify, plan and implement key projects to improve quality, reduce cost, increase productivity and improve cycle time resulting in significant business improvement and customer satisfaction. Responsib…
Skills: Medical Affairs, Process Improvement, Regulatory Compliance, Scientific Writing, Literature Analysis
United States · On-site
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Skills: SAS Programming, SDTM, ADaM, TLFs, CDISC Standards
United States · Remote OK
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice …
Skills: SAS, R, CDISC SDTM, CDISC ADaM, Oncology Clinical Trials
United States · Remote OK
ClinChoice is a global full-service CRO recognized for its commitment to professional development, strong work-life balance, and a collaborative, quality-driven “one-team” culture. We are currently seeking a Senior Clini…
Skills: Clinical Trial Management, Project Management, ICH-GCP Guidelines, Budget Management, Cross-functional Team Leadership
Pasig, Metro Manila, Philippines · On-site
Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, or related scientific disciplines required. Proven knowledge and training in high-level computing languages…
Skills: SAS, C/C++, Java, R, Python
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Manage regulatory submissions, renewals, and variations for OTC drugs within the EU and EMEA regions. Coordinate with cross-functional teams to ensure compliance and timely completion of regulatory action items and aggregate reports.
Requires a Bachelor's degree in Chemistry, Biology, or a related field. Candidates must have 4 to 5 years of experience in Regulatory Affairs within the pharmaceutical, cosmetic, or food supplement industries.
The Standard of Excellence
ClinChoice is a leading global full & functional service CRO, renowned for its exceptional product development and lifecycle management capabilities across the pharmaceutical, biotechnology, medical device, and consumer health sectors. With three decades of proven expertise and outstanding results, we excel in delivering top-tier services. Our deep regulatory expertise, clinical trial execution, and robust pharmacovigilance and biometrics capabilities position us as a trusted partner in global markets. ClinChoice proudly maintains a strong presence across the Americas, Europe, and Asia-Pacific, ensuring comprehensive support for our clients worldwide.
Offices: 300 Welsh Road, Building 5, Suite 201, Horsham, Pennsylvania 19044, US
The Standard of Excellence
ClinChoice is a leading global full & functional service CRO, renowned for its exceptional product development and lifecycle management capabilities across the pharmaceutical, biotechnology, medical device, and consumer health sectors. With three decades of proven expertise and outstanding results, we excel in delivering top-tier services. Our deep regulatory expertise, clinical trial execution, and robust pharmacovigilance and biometrics capabilities position us as a trusted partner in global markets. ClinChoice proudly maintains a strong presence across the Americas, Europe, and Asia-Pacific, ensuring comprehensive support for our clients worldwide.
Offices: 300 Welsh Road, Building 5, Suite 201, Horsham, Pennsylvania 19044, US
