Jobs
Instant Interviews
Tools

Resume Builder Build Professional Resume with Ease

Auto Apply Apply to hundreds of jobs on any platform effortlessly

Interview Questions Streamline interviews with ready-to-use questions

Salaries Discover market-driven salary insights across skillsets and geographies

Companies Explore leading companies actively hiring talent
Upskill New

Enhance your skills with our new Upskill features.

Powered by AllRounder.ai

Mock Interview Practice interviews in realistic simulations

Coding Practice Improve your coding skills with challenges

Certification Earn certifications to validate your skills

AI Learning Get trained with AI expert sessions

Career Guru AI insights for smarter career decisions
For Employers

Home

Jobs

Companies

Resume

Regulatory Affairs Compliance

Althera Laboratories India Pvt Ltd, Bangaore

5.0 - 8.0 years

7 - 15 Lacs

Bengaluru

Posted:2 weeks ago| Platform:

Apply Now

Skills Required

post approval Method transfer & validation report CMC Regulatory Compliance Regulatory Submissions Coa Bpr Review Regulatory Analytical chromatograms Gmp Compliance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. General Review of plant Site Master File, layouts, and valid GMP Compliance Certificate for its adequacy to support regulatory submission. Effectively implement post-approval commitment. Preferred candidate profile Review of CMC (Chemistry, Manufacturing, and Controls) Documents Self-motivated, detail-oriented, and highly organized professional Proven ability to collaborate and communicate effectively with diverse teams Proficient in Microsoft Word, Excel, and PowerPoint Fluent in English, with strong skills in speaking, comprehension, reading, and writing. Strong technical expertise in reviewing manufacturing site documentation.

More Jobs at Althera Laboratories India Pvt Ltd, Bangaore

Regulatory Affairs Compliance

Bengaluru

5.0 - 8.0 yrs

INR 7 - 15 Lacs

Althera Laboratories India Pvt Ltd, Bangaore

Not specified

No locations

1 Jobs

Login to

Please Verify Your Phone or Email

Confirm Action

Search

Profile

Bookmarks

Regulatory Affairs Compliance

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

More Jobs at Althera Laboratories India Pvt Ltd, Bangaore

RecommendedJobs for You

Regulatory Affairs Compliance

Company Secretary & Legal Executive

Regulatory Affairs Manger

Hiring Company secretory Location Karnal

Lead - Compliance(Legal)

Senior Regulatory Specialist

Analyst - Compliance GSK

Regulatory Executive

Manager Compliance

Walk In Drive - Assistant Manager - Company Secretary (9th June)

Login to

Please Verify Your Phone or Email

Confirm Action

Contact Us

Contact Us

Search

Profile

Bookmarks

Personal Settings

Regulatory Affairs Compliance

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

More Jobs at Althera Laboratories India Pvt Ltd, Bangaore