Assistant Manager

1 day ago

Mumbai Metropolitan Region, India Domnic Lewis International Full time

We are currently hiring for the role of "Assistant Manager - Regulatory Affairs and Pharmacovigilance" for a reputed Pharma company based in Mumbai.


Experience required : 7- 15 years into in handling regulatory and pharmacovigilance activities, In-depth understanding of CMC, non-clinical, and clinical data aspects for regulatory submissions.


Qualifications : B Pharm or Masters in Science experience with 7-8 years of operational experience in handling regulatory and PV activities; MBBS/ M. Pharm/ Ph.D. (Pharmacology/ Pharmaceutics) graduates preferred.


Job Responsibilities :

Principal Responsibilities

  • Ensure compliance with all company procedures, rules, and codes of practice, particularly regarding confidentiality and security of documents related to the company’s business.
  • Safeguard and prioritize the company's business interests at all times, maintaining and enhancing the company’s reputation.

Activities of the Regulatory Affairs & Pharmacovigilance Department:

  1. Health Authority Database Management:
  • Responsible for maintaining and uploading data on health authority databases (SUGAM, FDA, etc.).
  1. Coordination for Product Dossier:
  • Coordinate with global and local counterparts for product dossier preparation.
  • Compile and submit applications for product registrations (local manufacturing and imports), including drugs, medical devices, food supplements, etc.
  • Manage the CMC (Chemistry, Manufacturing, and Controls) section of the product dossiers.
  1. Regulatory Strategy & Compliance for Export Markets:
  • Assist in developing and implementing regulatory strategies for the export of drug products to international markets.
  • Ensure compliance with regulations in international markets, including Clinical Trials (CT) and Bioequivalence (BE) submissions to CDSCO.
  1. Preparation for SEC Meetings:
  • Assist the Senior Manager/Director of Regulatory Affairs and Pharmacovigilance in preparing SEC slide decks.
  • Organize mock SEC meetings with stakeholders and assist in other preparations for SEC meetings.
  1. Life-cycle Management:
  • Responsible for life-cycle management activities, including labeling, CMC changes, license renewals, artwork management, and product testing in compliance with local and international regulations and company SOPs.
  • Support artwork preparation and review.
  1. Inspection and Audit Preparation:
  • Support the RA/PV team in planning and preparing for health authority inspections and internal audits.
  1. SOP Development and Compliance:
  • Assist in the preparation of local SOPs.
  • Handle quality complaints, product recalls, deviations, CAPA (Corrective and Preventive Actions), and changes, ensuring the databases are updated in accordance with local SOPs.
  1. Quality Management Systems (QMS) Compliance:
  • Support the development and maintenance of QMS in compliance with Good Manufacturing Practices (GMP) and relevant standards.
  1. Pharmaceutical Responsibility and Compliance:
  • Act as a deputy for the local pharmaceutical responsibility coordinator, ensuring proper documentation and implementation of pharmaceutical SOPs, quality complaint management, and reconciliation.
  • Manage product complaints and coordinate investigations related to suspected falsified products.
  • Assist with recall execution, coordination with involved personnel, and traceability of affected batches.
  1. Global Database Maintenance:
  • Ensure timely data uploads and maintenance of global registration databases, complying with local and global guidance documents.
  1. General Responsibilities:
  • Perform any other tasks relevant to the functioning of the Regulatory Affairs and Pharmacovigilance Department, as requested by management.
  • Maintain a high level of discretion regarding confidential clinical studies and product information.


Minimum Requirements:

  • Bachelor’s in Pharmacy or Master’s in Science with 7-8 years of operational experience in handling regulatory and pharmacovigilance activities; MBBS/M. Pharm/Ph.D. (Pharmacology/Pharmaceutics) graduates preferred.
  • In-depth understanding of CMC, non-clinical, and clinical data aspects for regulatory submissions.
  • Proficiency in MS Office (Word, PowerPoint, Excel, etc.).
  • Ability to manage regulatory and PV activities in the absence of the Senior Manager.


Indispensable Qualities:

  • Professional and discreet approach to job responsibilities.
  • Tactful in face-to-face meetings and interactions.
  • Strong communication skills, both oral and written.
  • Ability to work independently with minimal guidance.
  • Flexible and capable of prioritizing tasks effectively.
  • Energetic, enthusiastic, and committed to tasks.
  • Ability to adhere to systems and standards while maintaining cordial relations.


Competencies Required for the Job:

  • Regulatory Knowledge: Ability to adhere to local (CDSCO) and international market regulations, and other legally enforceable requirements.
  • Drug Development Knowledge: Understanding of the drug development process from discovery to market introduction.
  • Responsiveness: Ability to mobilize resources and implement solutions quickly.
  • Risk/Benefit Analysis: Ability to assess and quantify the risk and benefits associated with drug products.
  • Scientific Knowledge: Ability to accumulate knowledge systematically and apply it to general principles.
  • Learning Agility: Ability to rapidly learn and retain new information without compromising comprehension.
  • Synthesis: Ability to bring together various elements of knowledge into a coherent, structured understanding.
  • Adaptability: Ability to adjust behavior and actions according to different environments, issues, and stakeholders.
  • Pedagogy: Ability to effectively teach and transmit knowledge using appropriate methods.


Important experiences or exposures required : 1. SUGAM 2. CMC 3. PV Activities 4 . Exposure on Domestic Markets is a must 5. CMC queries (Full lifecycle management).


Interested candidates can share their CV to musharraf.s@domniclewis.com

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