Careers at Raised Pharma

You would own formulation work from pre-formulation through to validated commercial manufacture, and the quality system that sits underneath it. The breadth matters here more than depth in any one form — on a given month you might be troubleshooting a dissolution profile on a tablet, stabilising an emulsion for a topical, and writing the validation protocol for a liquid.

Responsibilities

• Develop and optimise formulations across oral solid, oral liquid, topical semisolid and cosmetic dosage forms
• Run pre-formulation and excipient compatibility studies, and select lead formulations on data rather than preference
• Design and execute stability programmes, and interpret the results against the target market’s requirements
• Author and execute process validation protocols (PVP) and reports (PVD, PVR), and cleaning validation
• Write and maintain master formulae, batch records, specifications and SOPs to a GMP standard
• Support scale-up and technology transfer to manufacturing sites, including trial and validation batches
• Investigate deviations and out-of-specification results, and define corrective actions that hold
• Work alongside the regulatory team so that formulation decisions support the intended submission

What we are looking for

• Minimum five years’ hands-on formulation and/or QA experience in a pharmaceutical, nutraceutical or cosmetic manufacturing or development environment
• Demonstrated experience across more than one dosage form — oral solid, oral liquid, topical semisolid or cosmetic
• Working knowledge of GMP and of validation and stability principles
• B.Pharm, M.Pharm, M.Sc. or equivalent in pharmacy, chemistry or a related science
• Confident technical writing — protocols and reports that stand up to review
• Comfortable owning a problem end to end in a small, senior team

Register your interest ›

You would carry products through registration in the markets we serve, and act as the person who tells a client early — not late — that a formulation or a claim will not survive review. The role spans drugs, natural health products and cosmetics, which means the classification question is live on almost every project.

Responsibilities

• Determine product classification and the applicable regulatory pathway for target markets
• Compile, author and submit registration dossiers, including CTD/eCTD modules where they apply
• Prepare Health Canada submissions across DIN, NPN and Cosmetic Notification routes
• Prepare US submissions and support GCC registrations (SFDA, EDE, MOPH, NHRA and the GCC centralised route)
• Review labels, artwork and marketing claims before they are committed, and flag what cannot be substantiated
• Manage authority questions and deficiency responses through to decision
• Maintain the registered portfolio — variations, renewals and post-approval changes
• Track regulatory change across our markets and brief the business on what it means in practice

What we are looking for

• Minimum five years’ regulatory affairs experience covering pharmaceutical, natural health product or cosmetic products
• Direct experience preparing and filing dossiers with at least one of Health Canada, the FDA, the EMA or a GCC authority
• Familiarity with CTD/eCTD structure and with post-approval change management
• Sound grasp of labelling and claim substantiation requirements
• B.Pharm, M.Pharm, M.Sc., or a science degree with a regulatory affairs qualification
• Precise written English and the judgement to say no to a claim that will not hold

Register your interest ›