Sr. Manager - Frd Non-Orals

14-17 years

Not Disclosed

Remote

10 Jan. 1, 2025

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

Job Title: Sr. Manager - FRD Non-Orals
Date: Jan 1, 2025
Location: Tandalja - R&D
Company: Sun Pharmaceutical Industries Ltd

Key Responsibilities:

Technical Expertise:

Provide technical leadership in the formulation design, process optimization, and characterization of liposomal drug products.
Address complex formulation and manufacturing challenges through a science-driven approach.
Ensure compliance with global regulatory requirements (e.g., FDA, EMA) for liposomal generics.

Strategic Leadership:

Lead R&D projects focusing on liposomal formulations, ensuring alignment with organizational objectives.
Develop strategies for the design, development, scale-up, and commercialization of complex generics, particularly liposomes.
Collaborate with cross-functional teams, including Regulatory Affairs, Quality Assurance, Manufacturing, and Marketing, to drive project success.

Project Management:

Manage multiple R&D projects, ensuring timely delivery within budget and resource constraints.
Oversee the technology transfer process from R&D to manufacturing, ensuring scalability and robust processes.
Track key milestones and provide senior management with regular updates.

Regulatory and Compliance:

Contribute to the preparation of ANDA submissions for complex generics, including reviewing and authoring Module 3 documentation.
Ensure adherence to cGMP, GLP, and other applicable regulatory standards throughout development.

Team Development:

Mentor and guide a high-performing R&D team specializing in complex drug delivery systems.
Promote a culture of innovation, collaboration, and continuous learning within the team.

Qualifications:

PhD/MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related fields.

Experience:

Minimum of 14-17 years of experience in R&D for complex generics, with at least 5 years dedicated to liposomal formulations.
Proven expertise in developing and commercializing liposomal drug delivery systems.
Track record of successful ANDA filings for complex generics.

Skills & Competencies:

Profound understanding of liposomal technology, including formulation, characterization, and analytical techniques.
Strong knowledge of global regulatory guidelines and quality standards for complex generics.
Excellent project management, problem-solving, and decision-making abilities.
Strong leadership, communication, and interpersonal skills.

Key Performance Indicators (KPIs):

Timely completion of R&D milestones within budget.
Successful ANDA submissions and approvals for liposomal generics.
Efficiency of technology transfer processes to manufacturing.
Development of innovative formulations and cost-effective processes.

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Sr. Manager - Frd Non-Orals

Job Description

Key Responsibilities:

Qualifications:

Experience:

Skills & Competencies:

Key Performance Indicators (KPIs):

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