8.0 - 15.0 years

0 Lacs

hyderabad, telangana, india

On-site

Job Title: CMC Subject Matter Expert (Regulatory documentation workflows) Location: India Experience: 815+ years Domain: Pharma / Biologics / Regulatory CMC Role type: Contract role only to start At Replicant AI , we're building an AI-first documentation platform for life sciences starting with one of the most complex and high-impact areas: Module 3 (CMC) of the regulatory dossier. We're looking for a hands-on CMC Subject Matter Expert who deeply understands regulatory documentation and workflows, and is excited to shape how AI products are built for real pharma users. Roles & responsibilities Act as the CMC domain expert for our AI product, covering Module 3 (3.2.S / 3.2.P) end-to-end Provi...

Posted 1 week ago

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CMC (Authoring)-Writer(Bangalore) Celegence Systems

6.0 - 7.0 years

9 - 15 Lacs

bengaluru

Hybrid

Designation : CMC writer(Author) Job location: Jayanagar(Bangalore) Work mode: Hybrid(3 days a week) Role & responsibilities 6 years of prior CMC Authoring/Writing experience preferred. Hands on in Authoring of the documents . Expertise in Dosage forms and OTC products. Expertise in Formulations. Interested in expanding his/her knowledge of pharmaceutical manufacturing and testing as it pertains to eCTD Modules 2 and 3 writing and support labelling activities Experience in the pharmaceutical or CRO industry preferred Experience in pharmaceutical manufacturing or testing activities is mandatory. You need to be expert in Gap Analysis of the documents Work on the preparation of the documents In...

Posted 1 week ago

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CMC (Authoring)-Writer(Bangalore) Celegence Systems

3.0 - 8.0 years

5 - 15 Lacs

Bengaluru

Hybrid

Designation : CMC writer(Author) Job location: Jayanagar(Bangalore) Work mode: Hybrid(3 days a week) Role & responsibilities 3-7 years of prior CMC Authoring/Writing experience preferred. Hands on in Authoring of the documents . Expertise in Dosage forms and OTC products. Expertise in Formulations. Interested in expanding his/her knowledge of pharmaceutical manufacturing and testing as it pertains to eCTD Modules 2 and 3 writing and support labelling activities Experience in the pharmaceutical or CRO industry preferred Experience in pharmaceutical manufacturing or testing activities is mandatory. You need to be expert in Gap Analysis of the documents Work on the preparation of the documents ...

Posted 6 months ago

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