PHARMA WISDOM

Interested candidates can share with the below mentioned mail-Id : raghu@virchowbiotech.com

Raghurami Reddy Palugulla,

Sr. Manager-HR, Virchow Biotech Pvt. Ltd –Hyderabad.,

Mob- 09642996045 

Walk- In Drive for Regulatory Affairs Dept. in API Division- R&D Center.

Regulatory Affairs API RA Dept. in API Division,

Openings: 70
Job Title: Executive / Senior Executive Experience: 1 to 8 years in API RA field Education: B Pharma / M Pharma / M.Sc
Department: Regulatory Affairs
Job Profile:
1. 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.
2. Hands on experience on the preparation of DMFs and their registration processes in the major regulatory regions [US, Canada, Europe etc]..
3. 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.
4. Should have hands on experience on eCTD regulatory submission tools.
5. Should have knowledge on the requirements to respond to the deficiencies.
6. 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 / M.Sc
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.
12. Review and assessment of change controls and providing guidance to the team on proposed changes.
13. 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: 06.03.2020 (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

REGULATORY AFFAIRS/EXPERIENCE-BULK DRUGS/API-HYDERABAD

Department: Regulatory Affairs

Designation: Executive/Sr. Executive

Industry: Pharma/API

Experience: 2 to 6 years

CTC: Negotiable

Job Location: Sanath Nagar, Hyderabad

Roles and Responsibilities

• Preparation of Drug Master Files (DMF) in CTD / eCTD / Nees format for US, European Countries, Canada, Australia, Japan, GCC, Turkey and Korea as per customer/ business requirement.
• Preparation of amendments/ Annual Reports to USDMFs, CEP variations, EDMF Updates, Biannual updates to Canada DMFs and Annual updates to Korea DMFs, Japan DMFs.
• Review and approval of change controls.
• Submission of notifications to the customers pertaining to regulatory submissions as per the applicability.
• Responding to deficiency letters received from various regulatory agencies like USFDA, EU Agencies, TGA, Health Canada etc.
• Hands-on experience in Electronic submissions-Lorenz.
• Maintaining query database and response timelines.
• Tracking of variation submission timelines (Amendments, Annual Reports) to various Health Authorities
• Responsible for organizing meetings to address queries and variation submissions.
• Rendering customer support by preparing technical packages, Applicant" s Part Drug Master Files and responding to the technical queries received from customers.

• Preparation of pharmaceutical ingredients (API) and its intermediates.
• Analytical interpretation, trouble shooting & Plant performances.

Desired Candidates Please Share Your Updated Resume vivek.s@heterodrugs.com

Dear Aspirants,

1. Regulatory Affairs (3-4 Year's) 

    Location: Chennai

2. ARD (1 Year's)

    Location: Pondicherry

3. FRD (1 Year's)

    Location: Pondicherry

4. Production (4 to 8 Years)

Location: Pondicherry

Qualification: B.Pharm or B.Sc Chemistry / Any Degree

Should have a relevant working experience

Organization:

Aeon Formulations Pvt. Ltd

Send cv to

Pl apply with post name to hr@aeonf.com along with your current and Expected salary

Intas Pharmaceuticals Ltd - Openings for R&D (Analytical) / Manufacturing / Quality Control / Regulatory Affairs - Apply Now

Walk-In Interviews @ SMS Pharmaceuticals Limited

Production - B.Sc / M.Sc / B.Pharm (0-3 Years) 20 No’s

QC Wet Lab - B.Sc / M.Sc (1-3 Years) 4 No’s

QC GC - B.Sc / M.Sc (2-4 Years) 3 No’s

QC Review – B.Sc / M.Sc (4-6 Years) 2 No’s

QA & RA - B.Sc / M.Sc (1-3 Years) 3 No’s

Safety - M.Sc / B.Tech Chemical (1-3 Years) 2 No’s

ETP - BA / B.Com (0-1 Years) 2 No’s

(Above all positions are must having API Pharma experience)

Walk-in interview conducted from 17th to 20th February 2021, Preferable immediately joining.

Candidate must carry 1) Resume 2) Three Months’ Pay slips 3) Pass port size photo.

Male Candidates only.          

Interview Venue:-

SMS Pharmaceuticals Limited

Unit-II: Plot No. - 24 & 24 B and 36 & 37,

S.V. Co - Operative Industrial Estate, Bachupally,

Medchal-Malkajgiri District, Hyderabad-500 090,

Telangana, INDIA.

Email: admin_unit2@smspharma.com

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Dear Aspirants,

Greetings from BVR Solutions…..

We are looking for Fresher's & experienced candidates with good communication skills for Formulation PLANT (OSD & INJECTABLE) based @ Hyderabad.

Candidates can share their resumes to Email id: bvrcareers@gmail.com  / info@bvrsolutions.in

Contact:  9121514444 | 8185999958.

                   040-35115211

Shortlisted candidates will get a call from HR.

Address: BVR SOLUTIONS, plot no: 60 1^st floor 103, near arjun theatre (opposite to siri tiffins), jalavayu vihar road, western hills, KPHB, Hyderabad...

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Glenmark is hiring for "Officer - Regulatory Affairs (US Market)

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Interested candidate can share their resume at Simran.Gill@glenmarkpharma.com

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ORBIT PHARMACEUTICALS - Walk-In Interviews for Freshers & Experienced in Regulatory Affairs / Business Development on 12th Feb' 2021

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BioMatrix Healthcare Pvt. Ltd - Urgent Openings for Freshers & Experienced in Regulatory Affairs / F&D - QA / Packaging / Production Documentation

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