Corona Remedies
MANAGER/ SR. MANAGER - R.A
- Compensation
- Not disclosed
- Location
- Ahmedabad, GJ, India
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 10+ years
- Category
- Not specified
- Posted
Skills
Must have
- Qualification:
- Job Summary:
- • Lead regulatory strategy, due diligence, and compliance activities for international markets.
- • Manage product registrations, renewals, variations, and regulatory submissions within timelines.
- • Review dossiers, tender documents, labeling, and compliance-related documentation.
- • Develop regulatory strategies supporting product development, commercialization, and lifecycle management.
- • Monitor global regulatory changes and provide strategic recommendations to stakeholders.
- • Collaborate with cross-functional teams to ensure successful product launches and market expansion.
- • Liaise with health authorities, distributors, partners, and consultants for regulatory matters.
- • Manage regulatory inspections, audits, GMP interactions, and compliance requirements.
- • Resolve regulatory queries, deficiencies, and compliance risks through stakeholder coordination.
- • Mentor regulatory team members and drive continuous improvement through regulatory intelligence and best practices.
- > Regulatory Strategy & Compliance Management
- > Global Product Registration & Lifecycle Management
- > Health Authority Interactions
- > Regulatory Intelligence & Risk Assessment
- > Cross-Functional Stakeholder Management
- > Technical Dossier Review & Submission Management
- > Good communication
- > Ownership
Full description
- Position: Manager/ Sr. Manager - Regulatory Affairs
- Job Location: Corporate Office, Ahmedabad
- Experience required: 10 – 15 Years
- Qualification: ,M.Pharm/ B.Pharm/ M.Sc
Job Summary:
- Lead regulatory strategy, due diligence, and compliance activities for international markets.
- Manage product registrations, renewals, variations, and regulatory submissions within timelines.
- Review dossiers, tender documents, labeling, and compliance-related documentation.
- Develop regulatory strategies supporting product development, commercialization, and lifecycle management.
- Monitor global regulatory changes and provide strategic recommendations to stakeholders.
- Collaborate with cross-functional teams to ensure successful product launches and market expansion.
- Liaise with health authorities, distributors, partners, and consultants for regulatory matters.
- Manage regulatory inspections, audits, GMP interactions, and compliance requirements.
- Resolve regulatory queries, deficiencies, and compliance risks through stakeholder coordination.
- Mentor regulatory team members and drive continuous improvement through regulatory intelligence and best practices.
Required Skills:
> Regulatory Strategy & Compliance Management
> Global Product Registration & Lifecycle Management
> Health Authority Interactions
> Regulatory Intelligence & Risk Assessment
> Cross-Functional Stakeholder Management
> Technical Dossier Review & Submission Management
> Good communication
> Ownership