Home / Job / MSN Laboratories 70 Openings – Walk-In Drive for Regulatory Affairs on 3rd Apr’ 2021

MSN Laboratories 70 Openings – Walk-In Drive for Regulatory Affairs on 3rd Apr’ 2021

MSN Laboratories  70 Openings  – Walk-In Drive for Regulatory Affairs on 3rd Apr’ 2021

Job Description: (Regulatory Affairs – API Division )

Should have minimum of 1 to 8 years of experience in API Regulatory Affairs

Job Title: Executive / Senior Executive Experience: 1 to 8 years in API RA field

Education: B Pharma / M Pharma / MSc

Department: Regulatory Affairs

Job Title: Executive / Senior Executive Experience: 1 to 8 years in API RA field Education: B Pharma / M Pharma / MSc

Department: Regulatory Affairs

Job Profile:

Collecting and reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.

  1.  Hands on experience on the preparation of DMFs and their registration processes in the major regulatory regions [US, Canada, Europe etc]..

  2.  Hands on experience on preparation of drug master files, Applicants Parts, Tech Pack, life cycle management [updates and amendments] and drafting of response to deficiencies and customer DMF review comments for all global regions.

  3. Should have hands on experience on eCTD regulatory submission tools.

  4. Should have knowledge on the requirements to respond to the deficiencies.

  5. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.

Job Title: Junior Manager / Assistant Manager Experience: 1 to 8 years in API RA field Education: B Pharma / M Pharma / MSc

Department: Regulatory Affairs

Job Profile:

  1. Good scientific conceptual background to the level to evaluate the processes and procedures in the area of Quality, R&D, AR&D and Production.

  2. Manageable communication in English [should be able to manage regulatory and scientific discussions in the internal and external meetings and one to one interactions within the organization and with customers]

  3. Manageable knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.

  4. Thorough knowledge and hands on experience on the DMF registration and marketing authorization application systems in the major regulatory regions [US, Canada, Europe etc]..

  5. Hands on experience on preparation of drug master files, life cycle management and drafting of response to deficiencies and customer DMF review comments for all global regions.

  6. Should have knowledge on product developmental and the quality systems to ensure the regulatory compliance.

  7. Should have hands on experience on eCTD regulatory submission tools.

  8. Conducting meetings for the deficiencies received from various regulatory agencies and should have knowledge on the requirements to respond to the deficiencies. Ensuring that the accurate and adequate responses are sent to the authorities within the timelines defined by agencies.

  9. Thorough review and ensuring that the regulatory submissions are adequate and error free with minimum open issues and closing of open issues before filing or before the receipt of deficiencies.

  10. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.

  11. Reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.

  1. Review and assessment of change controls and providing guidance to the team on proposed changes.

  2. Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity.

Drug Regulatory Affairs API RA Dept.

Exp : 1 to 8 Years

Position: Junior Executive / Executive /Senior Executive / Junior Manager

Date of Interview : 03.04.2020 ( Saturday )

Interview Time : 9.00 AM to 1.00 PM

Venue Details :

MSN Laboratories Pvt. Ltd.,

R&D Center, Pashamylaram

Ph No : +91-8452304799 040-30438786

Work Location : MSN LS II & R&D Center

Apply for this position

Allowed Type(s): .pdf, .doc, .docx

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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