Agm/dgm Drugs Regulatory Affairs (api)
Year Chandigarh, Chandigarh, India
Job Description
Roles and Responsibilities
- Provide comprehensive regulatory support throughout the product lifecycle, including vendor selection, API development, scale-up, validation, dossier filing, query handling, and post-approval 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 out-of-specification (OOS) or out-of-trend (OOT) observations during manufacturing and testing of commercial-scale 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.
- In-depth 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, problem-solving, and decision-making skills.
- Effective communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders.
- Detail-oriented 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 Skills
drug 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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Job Detail
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Job IdJD3075652
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationChandigarh, Chandigarh, India
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EducationNot mentioned
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ExperienceYear