We seek to hire an Associate Regulatory Affairs to support our North America business. This role will be based in person in Hyderabad and is an 8-month temporary assignment to provide maternity leave coverage. The incumbent will carry out core regulatory activities including Authoring, compilation, and publishing of regulatory submissions and independently supporting the life cycle management activities for the externally manufactured products (Dr. Reddy’s and in-licensed products) and ensuring regulatory compliance and systems.
Responsibilities
- Authoring, compilation, and publishing of regulatory submissions inclusive of chemistry, manufacturing and controls supplements, current drug applications and generic drugs as assigned.
- Provide regulatory operational support for External Manufacturing operations including co-ordination with CMOs, obtaining required documents from different CMOs, change controls and master document reviews, regulatory submissions.
- Compilation of post approval Changes (Supplements PAS/CBE-30/CBE-0 & Annual Reports) for ANDAs managed by North America Generics (NAG).
- Authoring of Annual Reports of the drug products and submission within stipulated time frame.
- Assembles and maintains regulatory files of FDA communications.
- Providing regulatory input and support and as necessary for Cross Functional Teams for external products.
- Monitors and tracking of upcoming supplements and Annual Reports.
- Timely routine operational support to NAG External manufacturing -In licenses and out licensed products.
- Preparing Regulatory strategy notes, regulatory due diligence support and launch support for acquired products in consultation with team lead.
- Digitalization of external products.
- Need based publishing support to the team.
- Manage all GDUFA related submissions including fees, establishment registrations and self-identification, annual volume reporting etc.
📌 Associate Regulatory Affairs - External Manufacturing (Fixed Term Contract) (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad
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