Domnic Lewis International | Manager- International Regulatory Affairs

1 week ago


navi mumbai, India Domnic Lewis International Full time

We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai.


Position: Manager- International Regulatory Affairs

Experience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products)

Qualification: M. Pharm or B. Pharm


Responsibilities:

  • Prepare and review CTD and ACTD dossiers.
  • Coordinate with Plant and R&D to gather inputs necessary for regulatory submission.
  • Ensure plant compliance with regulatory standards.
  • Achieve monthly plan goals and promptly respond to queries.
  • Perform gap analysis and update Master data.
  • Review Change Controls, Stability Protocol, Clinical Trial Protocols, and Artworks.
  • Solicit feedback from all countries regarding respective variations and ensure their timely submission.
  • Manage renewals.
  • Update Master data.
  • Conduct regular follow-ups with the plant for documentation and review meetings.
  • Track and review document requirements for upcoming new filings in ROW and Emerging markets.

Knowledge and skills

  • eCTD, CTD, Validation, ICH requirements, USFDA Filings,
  • WHO Prequalification, MCC South Africa for Biological and
  • Biotech products
  • Has exposure to in-licensed dossier filing and out licensing


Interested candidate can reach out to me at pooja.j@domniclewis.com



  • Navi Mumbai, Maharashtra, India Domnic Lewis International Full time

    We are seeking a highly skilled International Regulatory Affairs Lead to join our team at Domnic Lewis International. This role offers an excellent opportunity for a career-minded professional to take on new challenges and contribute to the success of our organization.About the Role:The International Regulatory Affairs Lead will be responsible for ensuring...


  • Navi Mumbai, Maharashtra, India Domnic Lewis International Full time

    We are seeking a seasoned professional to join Domnic Lewis International as our Regulatory Affairs Director.About the Role:Develop and implement regulatory strategies to ensure compliance with international regulations.Collaborate with cross-functional teams to gather inputs necessary for regulatory submissions.Maintain plant compliance with regulatory...


  • Navi Mumbai, Maharashtra, India Domnic Lewis International Full time

    Job TitleManager- International Regulatory AffairsAbout the RoleWe are seeking a highly skilled Manager- International Regulatory Affairs professional to join our team at Domnic Lewis International in Navi Mumbai.Key ResponsibilitiesDevelop and review CTD and ACTD dossiers for regulatory submissions.Coordinate with Plant and R&D teams to gather necessary...


  • navi mumbai, India Domnic Lewis International Full time

    We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai.Position: Manager- International Regulatory AffairsExperience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products)Qualification: M. Pharm or B. PharmResponsibilities:Prepare and review CTD and ACTD...


  • Navi Mumbai, India Domnic Lewis International Full time

    We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai.Position: Manager- International Regulatory AffairsExperience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products)Qualification: M. Pharm or B. PharmResponsibilities:Prepare and review CTD and ACTD...


  • navi mumbai, India Domnic Lewis International Full time

    We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai. Position: Manager- International Regulatory Affairs Experience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products) Qualification: M. Pharm or B. Pharm Responsibilities: Prepare and review CTD and ACTD...


  • mumbai, India Domnic Lewis International Full time

    Engineering RecruiterWe’re looking for a dynamic Engineering Recruiter to join our team! If you thrive in a fast-paced environment, have a knack for sourcing top talent, and understand the nuances of the EPC & Oil & Gas sectors , we want you!What You’ll Do:Drive recruitment for technical and non-technical roles in the engineering industry.Build and...


  • Navi Mumbai, India Domnic Lewis International Full time

    We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai.Position: Manager- International Regulatory AffairsExperience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products)Qualification: M. Pharm or B. PharmResponsibilities:Prepare and review CTD and ACTD...


  • mumbai, India Domnic Lewis International Full time

    Position: HR Recruiter – Pharma Team (WFO/WFH/Hybrid)Office Location: Powai, MumbaiExperience – 2 years to 4 yearsEducational background – B. Pharm, M. Pharm, (Science graduates with B.sc in Chemistry, Biotechnology, Biochemistry, Microbiology, Forensic Science or any science background will be preferred only)Note: Only candidates with the above...


  • mumbai, India Domnic Lewis International Full time

    Position: HR Recruiter – Pharma Team (WFO/WFH/Hybrid) Office Location: Powai, Mumbai Experience – 2 years to 4 years Educational background – B. Pharm, M. Pharm, (Science graduates with B.sc in Chemistry, Biotechnology, Biochemistry, Microbiology, Forensic Science or any science background will be preferred only) Note: Only candidates with the above...


  • Navi Mumbai, India Domnic Lewis International Full time

    We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai.Position: Manager- International Regulatory AffairsExperience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products)Qualification: M. Pharm or B. PharmResponsibilities:Prepare and review CTD and ACTD...


  • Navi Mumbai, India Domnic Lewis International Full time

    We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai.Position: Manager- International Regulatory AffairsExperience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products)Qualification: M. Pharm or B. PharmResponsibilities:Prepare and review CTD and ACTD...


  • Navi Mumbai, India Domnic Lewis International Full time

    We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai. Position: Manager- International Regulatory Affairs Experience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products) Qualification: M. Pharm or B. Pharm Responsibilities: Prepare and review CTD and ACTD...


  • mumbai, India Domnic Lewis International Full time

    Engineering Recruiter We’re looking for a dynamic Engineering Recruiter to join our team! If you thrive in a fast-paced environment, have a knack for sourcing top talent, and understand the nuances of the EPC & Oil & Gas sectors , we want you! What You’ll Do: Drive recruitment for technical and non-technical roles in the engineering industry. Build...


  • mumbai, India Domnic Lewis International Full time

    Domnic Lewis has been mandated to hire for AM/DM- Human Resources (ER & IR )The AM/DM for Field HR, Industrial Relations (IR), Employee Relations (ER), and Legal Affairs will oversee all daily activities related to field issues across India. This role involves close collaboration with the Line Manager and Divisional Head to ensure smooth and efficient...


  • navi mumbai, India Domnic Lewis International Full time

    Domnic Lewis is currently hiring for an "DGM- Business Development and In-Licensing" role for a well known biopharmaceutical company based in Navi Mumbai. Experience : 10+ years in Business Development and in licensing for Biopharma/ Biosimilars domain companies preferred only . Qualifications : MBA + Degree in Science preferred Location : Navi Mumbai...


  • navi mumbai, India Domnic Lewis International Full time

    Domnic Lewis is currently hiring for an "DGM- Business Development and In-Licensing" role for a well known biopharmaceutical company based in Navi Mumbai.Experience : 10+ years in Business Development and in licensing for Biopharma/ Biosimilars domain companies preferred only.Qualifications : MBA + Degree in Science preferredLocation : Navi Mumbai...


  • navi mumbai, India Domnic Lewis International Full time

    Domnic Lewis is currently hiring for an "DGM- Business Development and In-Licensing" role for a well known biopharmaceutical company based in Navi Mumbai. Experience : 10+ years in Business Development and in licensing for Biopharma/ Biosimilars domain companies preferred only . Qualifications : MBA + Degree in Science preferred Location : Navi Mumbai...


  • mumbai, India Domnic Lewis International Full time

    Domnic Lewis has been mandated to hire for AM/DM- Human Resources (ER & IR ) The AM/DM for Field HR, Industrial Relations (IR), Employee Relations (ER), and Legal Affairs will oversee all daily activities related to field issues across India. This role involves close collaboration with the Line Manager and Divisional Head to ensure smooth and efficient...


  • mumbai, India Domnic Lewis International Full time

    Domnic Lewis has been mandated to hire for AM/DM- Human Resources (ER & IR)The AM/DM for Field HR, Industrial Relations (IR), Employee Relations (ER), and Legal Affairs will oversee all daily activities related to field issues across India. This role involves close collaboration with the Line Manager and Divisional Head to ensure smooth and efficient...