Ms. Hemlata Pawase

Qualification: M. Pharm

Specialization: Pharmaceutical Chemistry

Email: hemlatapawase05@gmail.com

Experience  : 5 Years, 10 months.

(Industry- 4 Years, 3 months and academics- 1 Year, 7 months)

Industry: Worked in Regulatory affair department at BDH Industries as Executive- Regulatory affair.

PROFILE:

• Preparation and review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities.

• Worked on various semi-regulated markets like, Asia: Srilanka, Myanmar; Africa: Mozambique, Zambia, Liberia and Madagascar; Latin America: Chile, Bolivia.

• Ensuring timely submission for new marketing authorization, variations and renewals, their follow up and approval in line with timings agreed with supervisor.

• Dossier submission of various dosage forms such as Tablets, Parenterals, Ophthalmic products and Ointments/creams

• Updating and maintaining the Registration Status of products in different countries.

• FDA Applications such as Additional Product Permission, etc.

• WHO - GMP Certification: COPP Application.

• Handling WHO- GMP renewal Application.

• Online product registration on SUGAM portal of CDSCO.

• Review of documents required for regulatory agencies (Viz. Analytical reports, Process Validation reports, Specification like RMS, FPS, PMS & stability data).

• Preparation / Review of labeling & packaging material and packing inserts.

• Preparation and Evaluation of Product Information Literature (PIL)

• Attending the queries raised by MOH of various countries.

• Communicating and Co-ordinating with various departments for collecting documents required to prepare the dossier or for complying queries raised by MOH.

Academics: Worked as Assistant professor in pharmaceutical chemistry department at Principal K. M. Kundnani College of Pharmacy at Cuffe Parade, Mumbai and Viva Institute of Pharmacy, Virar.

PROFILE: 

Teaching of Theory lectures for following subjects,

FYB.Pharm (Sem - II)

1) Pharmaceutical Organic Chemistry-I

2) Pharmaceutical Biochemistry

3) Pathophysiology 

SYB.Pharm (Sem - IV)

• Pharmaceutical Organic Chemistry-III

TYB.Pharm (Sem - VI)

1) Pharmaceutical Medicinal Chemistry-III

Practicals

1) Pharmaceutical Organic Chemistry (Sem -II & Sem III)

1) Pharmaceutical Medicinal Chemistry-III (Sem-VI)