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Demo S.A.Regulatory Affairs

Regulatory Affairs Manager (Pre- Approval) - DEMO Global Services

Hyderabadonsitemanager

Posted 2w ago · via Workable

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About this role

The Regulatory Affairs Manager (Pre- Approval) will lead regulatory strategy and submission readiness for assigned development products from early development through first approval. The role integrates product, formulation, process, analytical, stability, nonclinical, clinical and device information, as applicable, to identify regulatory risks, influence development decisions and establish scientifically defensible regulatory positions. The Manager will combine strategic scientific judgement with disciplined dossier planning, review and submission execution. Responsibilities Develop and maintain product-specific regulatory development plans covering legal basis or pathway, target markets, reference product strategy and authority engagement.…

Read the full description on Demo S.A.'s site →

What we'd score you on

reqspace match rubric

Five dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.

1

Skills match

We compare your skills against the role requirements.

2

Level fit

This role is manager-level. We check your trajectory against it.

3

Domain experience

Your work in the role's domain matters more than your years total. We weight recent and direct experience.

4

Recency

A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.

5

Location fit

This role is based in Hyderabad. We weight your proximity and willingness to relocate.

Score yourself on this role.
Free · no card · written explanation included
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