International Regulatory Affairs Executive

Claps Industries

Anand Nagar, Ahmedabad

₹15,000 - ₹40,000 monthly

Fixed

15000 - ₹40000

Earning Potential

40,000

Work from Office

Full Time

Min. 1 year

Good (Intermediate / Advanced) English

Job Details

Interview Details

Job highlights

26 applicants

Benefits include: Annual Bonus, PF

Job Description

• Responsible to prepare and review of dossier as per CTD / ACTD / Country specific guidelines • Responsible for dossier compilation and query response • Co-ordination with Cross Functional Team and Business Partners • To prepare and review all technical documents (SPEC, BMR, MFR, Validation reports etc) • Proficiency in literature search for products at various stage of R&D. • Ability to conduct secondary research and acquire information from internet sources, journals, public databases, etc. • Experienced and good hand-on drafting Clinical & non-clinical overview/summary. • Required knowledge of toxicity studies, BA-BE studies and clinical trials. • Working on regulatory agencies regarding pre-submission strategies, potential regulatory pathways. • Review of documents to ensure there are no gaps • Maintains the highest level of submission standards. • Maintains familiarity with evolving and/or new regulatory e-submission requirements • Familiarization with evolving guidance of Row markets

Job role

Work location

B1202 Infinity Tower, 100 Feet Rd, Prahlad Nagar, Ahmedabad, Gujarat 380015, India Anand Nagar, Ahmedabad

Department

Legal & Regulatory

Role / Category

Legal & Regulatory

Employment type

Full Time

Shift

Day Shift

Job requirements

Experience

Min. 1 year

Education

Graduate

Skills

MS Excel, MS Office Suite

English level

Good (Intermediate / Advanced) English

Degree/ Specialisation

Any B.Pharm (Hons.), Any M.Pharm, Any B.Pharm, Any Pharm.D (Atleast one)

Gender

Any gender

Interview details

Interview mode

In person

Interview address

B1202 Infinity Tower, 100 Feet Rd, Prahlad Nagar, Ahmedabad, Gujarat 380015, India

About company

Name

Claps Industries

Address

B1202 Infinity Tower, 100 Feet Rd, Prahlad Nagar, Ahmedabad, Gujarat 380015, India Anand Nagar, Ahmedabad

Job posted by Claps Industries

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