Job Engine: Regulatory Affairs

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Showing posts with label Regulatory Affairs. Show all posts
Showing posts with label Regulatory Affairs. Show all posts

Wednesday, 18 December 2024

Walk-in Interview For Analytical Development Laboratory (ADL) And Regulatory Affairs Department At Torrent Pharmaceuticals

December 18, 2024 0
Torrent PHARMA

We are HIRING Join Our Team

WALK-IN INTERVIEW

22ND DECEMBER (SUNDAY) 2024 @ MUMBAI

Job Location: R&D Centre Gandhinagar (Gujarat)

Dept.
Analytical Development Laboratory (ADL)

Grade
Executive

Experience
3 to 8 Years

Qualification
M.Pharm/ M.Sc

Job/ Skill Set
HPLC/GC method development, validation for OSD having exposure to regulated & India markets including: Complex generic, Oncology, F2F, derma/Cosmeceuticals having understanding of E&L/IVRT/IVPT/ Population bioequivalence/Skin blanching/IVIVC correlations etc

NI/GI & NDSRI' with LCMS/GCMS expertise, Solid state characterization (XRD/PSD/DSC/TGA/Raman/NIR/IR etc), Microbiology Probiotic subject matter expert

Hands on experience on preparation, review of standard test pro- cedure, study protocols, investigations reports for Raw material, formulation and well versed with USP/BP/IP/ICH

Dept.
Regulatory Affairs

Grade
Executive

Experience
3 to 8 Years

Qualification
M.Pharm / M.Sc

Job/ Skill Set
Dossier preparation and review of Module 1, 2 and 3 for US/EU Market

DCP/MRP/National Filing for various EU countries.

Dossier preparation and review of CMC documents as per the India market.

Formulation regulatory for solid orals/ Topicals/ Ophthalmics/ Solutions.

Management of life cycle and post approval variations.

Knowledge of Drugs/Cosmetics/FSSAI products for India market.

Knowledge of Labelling for US and India market.

LOCATION:
RESIDENCY HOTEL
Suren Road, Andheri - Kurla Rd., Opp. Cine Magic, Near W. E. Highway, Andheri (East), Mumbai - 400 093.

Time: 10:00 AM to 5:00 PM

→ Candidates interviewed during last 6 months need not apply In case of any Query you may contact


(M) +91 6359621127








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Hiring For Regulatory Affairs Department At Hetero Biopharma

December 18, 2024 0

Greetings from Hetero!!

We are hiring for the Regulatory Affairs Department (API) Division for HRF-I, Interested candidates can kindly share your profiles to prathap.p@hetero.com

Experience Required: 2-6Years

Description:

1. Preparation and Compilation of DMF's in-line with regulations of countries. Regulatory and Semi-Regulatory

2. Supporting to the concerned Marketing department/team's in terms of providing appropriate documents.

3. Coordinating effectively with all cross functional teams (QC, QA, R&D, and Production) to procure the documents and to develop the documents required for compilation of API DMFs.

4. Attending calls/Meetings with marketing teams, customers and plants regarding regulatory related issues as and when required.

5. Development of DMF's for registration of products in countries like US, Europe, Brazil, China, Russia markets.

6. Collecting, collating and evaluating scientific data received from plant/R&D.

7. Responsible for timely planning, coordination and submission of API DMF's/deficiencies in EMT markets.

8. Review of documents and compilation, identifying gaps, ensure suitability, acceptance etc.

9. Guidance to cross-functional teams and team members on EMT regulatory strategy and regional regulatory requirements.

10. Timely quality response to external customers on technical queries and requests.

11. Life Cycle management of the products.

12. Maintain compliance with the regulatory requirements.
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Saturday, 7 December 2024

Job Opportunities For Freshers And Experience Candidate At R&D,QA,QC, Production, Regulatory Affairs And Supply Chain & Logistics Department At Halewood Laboratories

December 07, 2024 0
Halewood Laboratories Pvt. Ltd.

Walk-In Interview

We are hiring for various roles in Halewood Laboratories. Come walk in and meet our hiring team for exciting career opportunities in different departments.

Experience: 0 to 5 Years

Positions Available:

• Research & Development(R&D)

• Quality Control (QC)

• Quality Assurance (QA)

• Production

• Regulatory Affairs

• Sales & Marketing

• Supply Chain & Logistics

• Finance & Accounts

What to Bring:

• Updated Resume

• Passport-size Photographs

• Experience Certificates (if any)

• Valid ID Proof

• Original and Photocopy of Educational Certificates

Date: 15-12-2024

Time: 10 AM-4PM

Venue: 310, Sankalp Square 2, Near Jalaram Temple, Paldi, Ahmedabad-380006. Job Locations: Vatva, Bavla, Changodar (Ahmedabad)

For More Information:

Visit: http://www.halewoodlabs.com/index.html

Feel free to reach out to us

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Saturday, 30 November 2024

Job Opportunities For Regulatory Affairs Department At Freyr Solutions

November 30, 2024 0
Join our Global Regulatory Intelligence Team! hiring fresher

Job Title - Regulatory Intelligence Associate

Experience - 0-1 year

Location- Hyderabad (WFH)

Education- Graduate/ Postgraduate in any life-science related disciplines (B.Pharm/ M.Pharm/ Food tech/ B.Tech/M.Tech)

Expected Skills -

1. Regulatory Affairs, understanding of global health authorities

2. Communication: Verbal and written communication, presentation skills.

3. Team Collaboration: Teamwork, conflict resolution, adaptability.

Role-
As a RI Associate, you would contribute towards various departmental processes such as collection of regulatory intelligence data, writing of summaries/ synopsis, quality check of data and uploading the data on product platform. These processes are running across the product categories of pharmaceuticals, medical devices and consumer products. Also, the scope of work covers the regulatory intelligence data across all the geographical regions. Depending upon your interest and work exigencies, you would be given an opportunity to specialize in one or more of these functions over the long term.

We invite interested candidates to share their CVs with us at rupali.chakraborty@freyrsolutions.com.

Join us in making a difference!
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Hiring For Regulatory Affairs Department At IQVIA

November 30, 2024 0

IQVIA is hiring "Regulatory Document Coordinators"

Experience - Fresher/Intern/Experienced

Work Location: Bangalore/Pune (Hybrid) - Night Shifts only (5 PM to 2 AM IST)

Required Skills - Regulatory Affairs & Certification is mandatory.

Educational Qualification: Science degree preferred, i.e. biology or microbiology, or biotechnology, pharmacy.

Note: Excellent English written and oral communication skills mandatory.

Process to apply:

Share resume tosreedhar.macherla@iqvia.com

Attachments to add in the email:

1. Updated Resume

2. Regulatory Affairs certificate
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Friday, 29 November 2024

Walk-in Interview For Quality Assurance And Regulatory Affairs Department At Biological E. Limited

November 29, 2024 0
Biological E. Limited

Walk-in-Interview

Biological E. Limited invites experienced, dynamic and self-motivated candidates with 3 to 8 years of experience for the below positions at its Vaccine Plant, Shamirpet, Hyderabad:

QUALITY ASSURANCE:

1. Position:- Executive/Sr. Executive/Asst. Manager

Qualification:-B. Pharmacy/M. Pharmacy/M. Sc. (Life Science)/M. Tech. (Life Science)

Required Skills

DRUG SUBSTANCE-IPQA (IN PROCESS):
AHands-on experience in Cell/Virus Culture Process/Bacterial/Line Clearance Activities, preparation of SOP/BPR/MFR/protocols and review, deviation, change control handling, and knowledge on investigational tools and CAPA management. Hands-on experience in OOS/OOT handling and analytical document review. Familiarity with the cell/viral bank system and maintenance.

DRUG PRODUCT-IPQA (IN PROCESS):
Participating in media fill activities and validating the process Reviewing log books and handling incidents in utility areas such as HVAC, water systems, and compressed air systems. Handling investigations, change controls, and in-process checks in the filling and packing area It is recommended that you have at least three years of experience in a Pharmaceutical GMP environment with aseptic practices
(MHRA, FDA, WHO)

Examine batch production records and log books of blending and filling

QA-VALIDATION & CSV

- The validation, qualification, and requalification of HVAC, process and packing equipment, utilities, elt.

- Creating and examining URS, DQ, FAT, SAT & SOPs for computerized systems, and analyzing the 10/00/PQ

- Computerized Systems Qualification protocols

- Compiling the executed protocols and writing a report. Reviewing the System Level Impact Assessment (SLIA), 21 CFR Part 11,

- EU Annexure 11, checklist, and identifying the qualification and validation requirements.

QA-QMS:

- TResponsible for handling internal audit, walkthrough, and quality risk assessment systems

- Trending in change control and deviations

- Organize and evaluate the monthly, quarterly, half-yearly, and annual trends of change controls and deviations

- Quality Matrix and other QMS activities

- Preparation of an audit tracker and periodic review schedule tracker for vendors. Implementing various CAPAs to improve quality systems

- Evaluating changes made through Change Controls by Inter-Departmental Functionalities through assessment, categorizing, and evaluation

REGULATORY AFFAIRS (Vaccine):

1. Position:- Asst./Deputy Manager/Senior Executive

Required Skills

- The candidate should have experience in India, World Health Organization, and RoW

- Preparation and review of regulatory submission packages related to Indian NRA, such as post-approval change and marketing authorization applications, Assisting in responding to queries for various regulatory authorities

- The preparation of dossiers/submission packages for NRA submissions, as well as dossiers for registration in ROW countries. The Documentation database that is available with RA is kept up-to-date. Collaborating with cross-functional departments such as QA, QC, Production, Warehouse,Distribution and Marketing, and Product Lifecycle management
Regular interaction with A documentation for updating master filesReview of pack profiles and artwork (labels and package inserts). Recombinant Products require approval from RCGM/GEAC

-- Interested candidates may walk-in with an updated CV, latest increment letter and the last 3 months payslips, along with education and other relevant documents on Saturday, December 07, 2024 from 09:30 am to 02:00 pm at Biological E. Limited, Aditya Enclave, Venkatagiri, Road No. 35, Jubilee Hills. Hyderabad, Telangana 500033.

-- PS: If you have already attended the interview in the past 6 months or if we have already offered you a position, please do not attend. Candidates who are unable to attend the interview may send in their CVs at Careers Biologicale.com


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