Agm/dgm Drugs Regulatory Affairs

7 months ago

Chandigarh, India Ind-Swfit Full time

**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 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

  • Drug Regulatory Affair

    1 month ago

    Chandigarh, Chandigarh, India Maya Biotech PVT LTD Full time

    **Position**: Drug Regulatory Affairs Executive **Industry**: Pharmaceutical Manufacturing (Third-Party Manufacturer) **Location**: Chandigarh, Baddi **About Us** We are a leading pharmaceutical company specializing in injectable formulations. With a strong commitment to quality and regulatory compliance, we provide innovative and high-quality solutions...

  • Am - Drug & Regulatory Affairs (Pharmaceutical

    4 days ago

    Chandigarh, India Maya Biotech PVT LTD Full time

    Dossier preparation, compilation and review. - Preparing of STS,STP,COA,STABILITY DATA. - Knowledge of CTD & ACTD Studying scientific and legal documents - gathering, evaluating, organising, managing and collating information in a variety of formats - ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) -...

  • Regulatory Affairs Executive

    18 hours ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNCSalary: Up to 5.5 LPACompany: ConfidentialLocation: Near ChandigarhJob DescriptionPreparation of New Drug Master files for USA, EDQM, Europe, Australia, Japan, Canada, China, Brazil and Rest of World for accuracy as per their individual regulatory requirements.Preparation of DMF’s...

  • Regulatory Affairs Executive

    5 hours ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNC Salary: Up to 5.5 LPA Company: Confidential Location: Near Chandigarh Job Description Preparation of New Drug Master files for USA, EDQM, Europe, Australia, Japan, Canada, China, Brazil and Rest of World for accuracy as per their individual regulatory requirements. Preparation of...

  • Regulatory Affairs Executive

    1 hour ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNCSalary: Up to 5.5 LPACompany: ConfidentialLocation: Near ChandigarhJob DescriptionPreparation of New Drug Master files for USA, EDQM, Europe, Australia, Japan, Canada, China, Brazil and Rest of World for accuracy as per their individual regulatory requirements.Preparation of DMF’s...

  • TalentXplore | Regulatory Affairs Executive

    6 hours ago

    chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNCSalary: Up to 5.5 LPACompany: ConfidentialLocation: Near ChandigarhJob DescriptionPreparation of New Drug Master files for USA, EDQM, Europe, Australia, Japan, Canada, China, Brazil and Rest of World for accuracy as per their individual regulatory requirements.Preparation of DMF’s...

  • Regulatory Affairs Director

    3 days ago

    Chandigarh, Chandigarh, India TalentXplore Full time

    Job OverviewTalentXplore is seeking a seasoned Regulatory Affairs Director to lead our regulatory strategy and compliance efforts. This role will oversee the development and implementation of regulatory strategies for product registrations in the UK and other MHRA-regulated markets.Key Responsibilities:Regulatory Strategy and Compliance:• Develop and...

  • Head of Regulatory Affairs

    4 days ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNCSalary:Up to 24 LPACompany:ConfidentialLocation:Near ChandigarhKey Responsibilities:Regulatory Strategy and Compliance:Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets.Ensure compliance with MHRA regulations, guidelines, and...

  • Head of regulatory affairs

    5 days ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNCSalary: Up to 24 LPACompany: ConfidentialLocation: Near ChandigarhKey Responsibilities:Regulatory Strategy and Compliance:Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets.Ensure compliance with MHRA regulations, guidelines, and...

  • Regulatory Affairs Director

    5 days ago

    Chandigarh, Chandigarh, India TalentXplore Full time

    Job Title: Head of Regulatory AffairsCompany Overview: TalentXplore is a leading pharmaceutical company that operates globally.Salary: Up to 24 LPALocation: Not SpecifiedKey Responsibilities:Strategic Planning: Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets, ensuring compliance with MHRA...

  • Head of Regulatory Affairs

    4 days ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNC Salary: Up to 24 LPA Company: Confidential Location: Near Chandigarh Key Responsibilities: Regulatory Strategy and Compliance: Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets. Ensure compliance with MHRA...

  • Head of Regulatory Affairs

    5 days ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNC Salary: Up to 24 LPA Company: Confidential Location: Near Chandigarh Key Responsibilities: Regulatory Strategy and Compliance: Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets. Ensure compliance with MHRA regulations, guidelines, and...

  • Head of Regulatory Affairs

    5 days ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNCSalary: Up to 24 LPACompany: ConfidentialLocation: Near ChandigarhKey Responsibilities:Regulatory Strategy and Compliance:Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets.Ensure compliance with MHRA regulations, guidelines, and...

  • Head of Regulatory Affairs

    6 days ago

    Chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNCSalary: Up to 24 LPACompany: ConfidentialLocation: Near ChandigarhKey Responsibilities:Regulatory Strategy and Compliance:Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets.Ensure compliance with MHRA regulations, guidelines, and...

  • TalentXplore | Head of Regulatory Affairs

    6 days ago

    chandigarh, India TalentXplore Full time

    Head of Regulatory Affairs in Leading Pharmaceutical MNCSalary: Up to 24 LPACompany: ConfidentialLocation: Near ChandigarhKey Responsibilities:Regulatory Strategy and Compliance:Develop and implement regulatory strategies for product registrations in the UK and other MHRA-regulated markets.Ensure compliance with MHRA regulations, guidelines, and...

  • Drug Safety Physician

    7 months ago

    Chandigarh, India MEDVARSITY ONLINE LIMITED Full time

    Drug Safety Physician role. Attached is the JD for your reference. Experience required: 0 - 2 years Qualification requirements: MBBS or MD Vacancies: 5 Work Location: Chandigarh Office Job responsibilities: - Providing medical advice to PV Scientists to assist them with processing of ICSRs - Review of published literature articles/abstracts -...

  • Faculty Position in Pharmaceutical Sciences

    2 weeks ago

    Chandigarh, Chandigarh, India Chitkara University Full time

    Company OverviewChitkara University is a leading institution in the field of pharmacy, ranked 19th for Pharmacy by NIRF 2024. Our university offers various programs in pharmaceutical sciences, including B.Pharm, Pharm.D., Pharm.D. (Post Baccalaureate), M Pharmacy and M.Sc. Pharmacovigilance & Clinical Research.Salary Range: ₹ 8-12 Lakhs per annumJob...

  • Chitkara University | Assistant Professor-Chitkara College of Pharmacy

    6 days ago

    chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh.Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Academic Faculty Member for Pharmacy Program

    3 weeks ago

    Chandigarh, Chandigarh, India Chitkara University Full time

    Chitkara University, a renowned institution in Punjab and Himachal Pradesh, invites applications for the position of Assistant & Associate Professor in Chitkara School of Pharmacy. This esteemed college has been ranked 19th for Pharmacy by NIRF 2024 and offers full-time courses in pharmacy, including B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Chitkara University | Assistant Professor-Chitkara College of Pharmacy | chandigarh

    1 month ago

    chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh. Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...