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Quality & Regulatory Affairs Specialist

maneuver-marketing · Singapore
Full-timeOperationsMarketing & Media$128,000–$173,000/yr
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About the Quality Regulatory Affair Specialist role

Quality Regulatory Affair Specialist positions focus on delivering results in their domain. This page aggregates open Quality Regulatory Affair Specialist roles and what employers typically expect.

BUILD, SCALE & OPERATE LEADING DTC BRANDS ALONGSIDE A-PLAYERS MANEUVER MARKETING Our Vision, Mission & Success are fuelled by our commitment to be a driving force of positive change to the health of everyday consumers, providing conscious, high-quality & innovative supplement products. In just 5 years, we kicked off our own DTC Health & Wellness brand from scratch and scaled it to USD$100M+ in annual sales, serving more than 3,000,000 customers worldwide with an average of 4,000 daily orders across 9 SKUs. These results caught the attention of The Financial Times https://www.ft.com/high-growth-asia-pacific-ranking-2023, as they ranked us among APACs top High-Growth Companies. We have also been awarded 2nd place on the E50 Awards https://www.sph.com.sg/media-centre/media-releases/fifty-local-smes-honoured-for-pioneering-success-and-innovation-at-30th-e50-awards/, jointly organised by The Business Times and KPMG in Singapore. This is just the beginning of our journey, and you could be part of the next stage of our growth! THE ROLE We’re hiring a Quality & Regulatory Affairs Specialist to be the technical backbone of our Product function, mainly Product Operations. Reporting to the Head of Product, you’ll own production quality oversight, troubleshooting, product testing and stability, and claims evidence, with US ingredient and regulatory requirements as a required supporting skillset. This is a hands-on, individual-contributor role for someone comfortable being the only technical voice in a commercially-led team and managing quality through contract manufacturers rather than an owned plant. Based in Singapore, you’ll manage US and Australia-based CMO partners mostly remotely (occasional travel and some night calls given US time zones) and hold finished-goods release sign-off. Ultimately, you’ll help us ship products that enrich customers’ lives, made safely, within each market’s laws, on time, and with a mindset that supports the whole team. WHAT YOU’LL DO OWN QUALITY OVERSIGHT AND PRODUCTION TROUBLESHOOTING - Diagnose and resolve production quality problems with our CMO partners, and set production/quality standards before a new product goes into manufacturing - Review production QC, consolidate batch records, close out CAPA, and hold finished-goods release sign-off - Own adverse event reporting (AER); audit CMO facilities when needed VERIFY PRODUCTS AND RUN STABILITY TESTING - Interpret identity, potency, and probiotic viability results to confirm each product matches its label and holds to end of shelf life - Manage the accelerated and real-time stability program end to end, from protocol review to launch sign-off GENERATE CLAIMS EVIDENCE - Scope and manage benefit/proof studies on existing products (literature, clinical studies, CRO/IRB) to strengthen what we can say about them CARRY US INGREDIENT AND REGULATORY REQUIREMENTS - Determine NDI/GRAS/ODI status and confirm permitted ingredients, dosage limits, and market requirements - Maintain ingredient dossiers and scientific substantiation SUPPORT THE WIDER TEAM - Give technical input on ingredient sourcing, formulation feasibility, and interaction/exposure checks; technically qualify new CMOs, suppliers, and labs - Partner with supply chain on batch-release readiness, give marketing substantiated claims language, and give customer service credible technical answers WHAT WE’RE LOOKING FOR - A scientific/technical background (food science, chemistry, nutrition, pharma/biotech, or related) - Experience setting production quality standards and managing quality through CMO/CDMO partners — batch records, CAPA, release — rather than an owned site (direct facility auditing a plus) - Able to interpret stability and ingredient testing data (probiotic or botanical a plus), COAs, and QC results critically — you won’t design assays, but you must know what the data means - Hands-on US ingredient/regulatory experience in a regulated consumer category — NDI/GRAS, permitted ingredients, FD…

Salary estimate

$128,000 – $173,000/yr
Provided by the employer.

Skills for this role

Sales

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