Granules India Hiring MSc,M.pharma for Regulatory Affairs

Granules India is hiring in Regulatory Affairs.Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, India.  Interested and eligible candidates can share resume at sharad.chandra@granulesindia.com

Vacancy Details :

  • Company Name: Granules India
  • Location : Hyderabad( Gagillapur )
  • Post Name: Regulatory Affairs
  • Department: Regulatory Affairs
  • Qualification: MSc,M.pharma
  • Experience: 4 to 8 years
  • No of Vacancies: 03
  • Details of Salary: Details not provide by recruiter
  • Contact: sharad.chandra@granulesindia.com
  • Mode of application : Online
  • Selection Process: Personal interview

Job Description/Skills Required :

 Hiring For Regulatory Affairs in Granules India Ltd ! If interested candidates can share your resume to mentioned mail ID

sharad.chandra@granulesindia.com

Position: 1 – Regulatory Affairs – Executive/Sr.Executive/Asst Manager- Labeling (Europe):

1. Responsible for the global labelling activities of Granules to provide high quality information to Health Care Professionals and consumers whilst minimizing product liability risks.

2. Responsible for preparation and updates of Product Information documents such as Patient Information Leaflet (PIL), SmPC, labeling texts for assigned products

3. Organise and lead the creation of high quality documents co-ordinating with internal and/or external experts including the preparation of responses to labelling-related Health Authority queries. – 

Education: MSc/ M Pharm with 4-8 years experience in Regulatory Affairs working in labeling of Europe &/ US; Excellent written and oral English, Mandatory 60% marks in academics;

Position: 2 – Regulatory Executive/Sr.Executive/Asst Manager-CMC (Europe):

1. Responsible for the authoring and preparation of CMC documents for Europe dossiers

2. Good knowledge on DCP, NP & RUP; well versed with all national competent Agencys websites in Europe and respective regulatory requirements

3. Can able to work independently with minimal support form team lead for the creation of high quality CMC documents co-ordinating with internal and/or external experts including the preparation of responses related to Health Authority queries.

4. Experience in handling m1, m2, m4, m5 is additional advantage.

Education: MSc/ M Pharm with 4-8 years experience in Regulatory Affairs working in CMC – Europe – Excellent written and oral English; – Academics: Minimum 60%.

Position: 3 – Regulatory Executive/Sr.Executive/Asst manager-CMC (Canada):

1. Responsible for the authoring and preparation of CMC documents for Canada dossiers

2. Good knowledge on submitting DINA, ANDS; well versed with all national competent Agencys guidelines

3. Can able to work independently with minimal support form team lead for the creation of high quality CMC documents co-ordinating with internal and/or external experts including the preparation of responses related to Health Authority queries.4. Experience in handling m1, m2, m4, m5 is additional advantage.

Education: MSc/ M Pharm with 4-8 years experience in Regulatory Affairs working in CMC – Canada Excellent written and oral English –Academics: Minimum 60%

  • Placement at Granules – Formulation plant – R&D center-Gandimaissamma x roads-Gagillapur (Near Kazipally)- Hyd.

How to Apply: share resume at sharad.chandra@granulesindia.com

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