Senior Manager

12-18 years

Not Disclosed

Delhi

10 Oct. 8, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Gracure Pharmaceutical Ltd. is Hiring for Drug Regulatory Affairs Department

Position: Senior Manager
Department: Regulatory Affairs (Canada, Australia, and UK)
Qualification: M. Pharma
Experience Range: 12 to 18 years
Location: New Delhi

Roles and Responsibilities:

Collaborate with R&D and stakeholders to facilitate timely filing and review of documents for EU, UK, Canada, and Australia related to solid oral and topical dosage forms, focusing on regulatory strategy and cost implications.
Plan and execute regulatory affairs (RA) strategies for extension projects in collaboration with partners.
Innovate regulatory strategies that allow flexibility in dossiers and identify cost-saving opportunities.
Prepare RA strategies in partnership with stakeholders, emphasizing cost-effectiveness.
Ensure compliance with regulatory requirements throughout the development process in collaboration with R&D and partners.
Manage document availability to ensure regulatory adequacy for timely technology transfers.
Guide the team in gathering and reviewing documents from various stakeholders to create high-quality dossiers for submission according to RACI timelines.
Assist the team in responding to queries from partners and regulatory agencies.
Ensure prompt submission of responses to facilitate approvals and product launches.
Assess change controls for regulatory adequacy and requirements.
Oversee lifecycle management of products to ensure a smooth market supply.

Interested candidates can share their resumes at: aakansha.agarwal@gracure.com

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Senior Manager

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