Jobs / United States / Clinchoice INC
Regulatory Affairs – CMC Consultant
Clinchoice INC · 🇺🇸 United States
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 17 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 5 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Clinchoice INC paid sponsored hires in similar roles1 certified filing for “Strategist, Regulatory Affairs” (Regulatory Affairs Specialists) in PA: $90k–$90k, median $90k. Most were filed at wage level III (100%) — 3 lottery entries, ≈46% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Clinchoice INC
The US Department of Labor certified 17 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 5 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Clinchoice INC →
About the role
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 is searching for a Regulatory Affairs CMC Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. About the Role We are seeking an experienced Regulatory CMC professional to support Client’s pharmaceutical and self-care portfolio. This role will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global regulatory submissions . The successful candidate will partner closely with Regulatory Affairs, R&D, Supply Chain, Quality, and other cross-functional teams to develop and implement effective CMC regulatory strategies. Key Responsibilities • Lead or support Regulatory CMC strategy for new product development and lifecycle management programs. • Provide CMC regulatory guidance for pharmaceutical and self-care products across global markets. • Develop, review, and maintain CTD Module 2.3 and Module 3 documentation. • Prepare and review CMC content for regulatory submissions, including new applications, variations, and post-approval changes. • Assess proposed CMC changes for regulatory impact, compliance, risks, and submission requirements. • Provide regulatory guidance on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC topics. • Act as the CMC representative on cross-functional product development and lifecycle management teams. • Partner with R&D, Manufacturing, Quality, Supply Chain, and Regulatory colleagues to resolve CMC issues and develop practical regulatory strategies. • Support regulatory agency interactions and responses to CMC-related questions, as required. • Manage regulatory risks and develop appropriate mitigation and contingency strategies. • Ensure ongoing regulatory compliance and successful implementation of approved CMC changes. • Contribute to process improvements, simplification initiatives, and development of effective CMC ways of working. Required Qualifications • Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences , or a related discipline. • Strong experience in Regulatory Affairs CMC and/or pharmaceutical product development . • Experience with CTD Modules 2.3 and 3 and CMC submission documentation. • Knowledge of global regulatory requirements related to pharmaceutical CMC. • Experience with new product development and post-approval lifecycle management . • Strong understanding of CMC regulatory requirements involving manufacturing, formulation, analytical testing, specifications, and stability. • Experience working effectively with cross-functional teams. • Strong project management, communication, problem-solving, and stakeholder-management skills. Preferred Experience • Experience supporting OTC, self-care, consumer health, or pharmaceutical products . • Experience working across multiple global markets and regulatory regions. • Experience interacting with health authorities or supporting responses to regulatory questions. • Ability to influence cross-functional teams and provide clear, practical regulatory guidance. What You’ll Bring We are looking for someone who combines strong technical CMC expertise with excellent regulatory judgment, communication, and collaborat