Senior Manager 2

5+ years

Not Disclosed

Ahmedabad

10 Jan. 5, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Senior Manager 2 - Regulatory Affairs
Date: December 23, 2024
Location: Ahmednagar - Regulatory Affairs, Sun Pharmaceutical Industries Ltd

Job Summary:
Sun Pharmaceutical Industries Ltd is seeking a Senior Manager 2 to manage the operations of the Site Regulatory department and coordinate with other departments of the plant and corporate regulatory teams. This position will play a key role in the compilation and filing of Drug Master Files (DMFs) for various international markets, including the USA, Europe, Canada, and other regions. The role also involves managing updates, responses to regulatory queries, and ensuring compliance with applicable regulatory requirements.

Key Responsibilities:

DMF Management and Submissions:

Manage the proper functioning of the Site Regulatory department and coordinate with other departments for the compilation of data required for DMF submissions.
Handle Drug Master File (DMF) submissions and responses to regulatory authorities, ensuring compliance with US, Europe, Canada, and other countries regulatory requirements.
Ensure the annual updating and renewals of DMFs (USDMF, CEP, Canada DMF, MRP, DCP procedures).
Coordinate with CRA (Regulatory Affairs) for updating various changes in the DMF and responses to regulatory authorities.

Regulatory Queries and Deficiencies:

Respond to deficiencies received from regulatory authorities in coordination with CRA.
Address customer queries and provide responses in collaboration with CRA.

Document Review and Approval:

Review and approve Change Control and Annual Product Review documents.
Oversee the review and approval of Specifications & ATPs to ensure regulatory compliance.
Ensure that any changes, modifications, incidents, or investigations with regulatory impact are reported to CRA promptly.

Training and Team Coordination:

Identify training needs within the regulatory team and other departments, and organize relevant training sessions to ensure continuous compliance and development.

GMP Documentation:

Prepare, review, and approve Good Manufacturing Practice (GMP) documents related to regulatory activities.
Manage Change Control extension requirements and ensure necessary actions are taken in compliance with regulatory standards.
Close Change Controls in Trackwise after filing and obtaining approval.

Quality Assurance and Safety:

Identify and immediately highlight any quality-related issues or concerns that arise.
Ensure the proper use of personal protective equipment (PPE) and compliance with safety regulations during all activities.

Education and Experience:

Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, or a related field.
Minimum 8-12 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
In-depth knowledge of DMF submissions, regulatory processes, and compliance for markets such as USA, Europe, Canada, and others.
Hands-on experience with Regulatory Affairs Management tools and systems, including Trackwise and GMP documentation.
Strong knowledge of Change Control procedures and regulatory documentation.

Key Skills and Attributes:

Regulatory Knowledge: Strong understanding of regulatory requirements for drug master files (DMFs) and GMP compliance.
Communication Skills: Strong written and verbal communication skills to effectively interact with regulatory authorities, customers, and internal teams.
Leadership and Coordination: Ability to manage a team, collaborate with multiple departments, and ensure timely delivery of regulatory submissions and responses.
Attention to Detail: Excellent attention to detail, particularly in reviewing regulatory documents, specifications, and change controls.
Problem-Solving: Proactive approach to identifying issues and resolving problems related to regulatory compliance.
Training and Development: Experience in identifying training needs and organizing training programs.

This is a strategic role within Sun Pharmaceutical Industries Ltd., focusing on ensuring the proper management of regulatory documentation, compliance with global regulatory requirements, and supporting the growth and quality of the organization’s pharmaceutical products. The Senior Manager 2 will contribute significantly to the successful operation of the regulatory affairs department.

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