Agm/dgm Drugs Regulatory Affairs

2 weeks ago

Chandigarh, Chandigarh, India Ind-Swfit Full time

Roles and Responsibilities

  • Provide comprehensive regulatory support throughout the product lifecycle, including vendor selection, API development, scaleup, validation, dossier filing, query handling, and postapproval life cycle management.
  • Support the Analytical Research Development and Chemical Research Division in the development of new APIs and proposed updates to existing APIs.
  • Collaborate with Manufacturing and Quality (Quality Assurance & Quality Control) departments to ensure smooth API supplies and compliance with regulatory requirements.
  • Review Technology Transfer Documents (TTDs) issued by the Chemical Research Division and technology transfer dossiers for adequacy.
  • Review and provide regulatory support for deviations, Corrective and Preventive Actions (CAPA), and investigation reports related to outofspecification (OOS) or outoftrend (OOT) observations during manufacturing and testing of commercialscale batches.
  • Assist in the review of technical and quality agreements.
  • Support and participate in audits conducted by customers and regulatory authorities, addressing any comments or concerns raised during the audit process.
  • Review New Drug Master Files (DMFs) for various countries, including USA, EDQM, Europe, Australia, Japan, Canada, China, Brazil, and Rest of World, ensuring adequacy and compliance.
  • Review DMF amendments, updates, and variations for multiple regulatory authorities.
  • Review open parts of Drug Master Files for adequacy.
  • Review responses to regulatory deficiencies received from regulatory agencies or customers to ensure adequacy and compliance.
  • Review vendor documents for key starting materials and intermediates of APIs according to regulatory guidelines.
  • Evaluate the impact of process, facility, batch size, and analytical document changes on regulatory filings.
  • Review and approve change notifications to customers.
  • Coordinate with Plant QA, QC, and Production departments to meet document and sample requirements for regulatory submissions in a timely manner.
  • Provide support in obtaining toxicological studies for new APIs not listed in the approved drug list of the Central Drugs Standard Control Organization (CDSO) to acquire Drug Manufacturing Licenses.
  • Assist in the renewal of DUNS numbers for the Derabassi and Jammu sites.
  • Approve declarations, letters of access, letters of engagement, cover letters, and change controls.
  • Define the responsibilities and organizational structure of the Drug Regulatory Affairs department.
  • Responsible for conducting vendor audits to ensure compliance with regulatory standards.

Qualifications:

  • Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, or related field.
  • Minimum of 15 years of experience in Regulatory Affairs within the pharmaceutical industry.
  • Indepth knowledge of global regulatory requirements, including FDA, EDQM, EMA, TGA, PMDA, Health Canada, NMPA, ANVISA, and other relevant authorities.
  • Strong understanding of API development, manufacturing processes, and quality control systems.
  • Proven track record of successfully managing regulatory submissions, approvals, and audits.
  • Excellent analytical, problemsolving, and decisionmaking skills.
  • Effective communication and interpersonal skills to collaborate with crossfunctional teams and external stakeholders.
  • Detailoriented with a high degree of accuracy and ability to work under pressure.
  • Ability to multitask and prioritize tasks effectively.
  • Familiarity with relevant software and systems used in regulatory affairs.

Role:

  • Head
  • Regulatory Affairs
  • Salary:


Not Disclosed by Recruiter
  • Industry:
  • Pharmaceutical & Life Sciences
  • Department:


Legal & Regulatory
  • Role Category:
  • Corporate Affairs
  • Employment Type:
  • Full Time, Permanent
  • Key Skillsdrug regulatory affairs
Active Pharmaceutical Ingredient

analytical

Regulatory Affairs

api

Dmf

US Market

API Manufacturing

Skills highlighted with '' are preferred keyskills

  • Education
  • UG:
  • B

Pharma in Pharmacy- PG:

  • M.Pharma

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