Regulatory Affairs Officer

7 days ago


Chandigarh, India MEDVARSITY ONLINE LIMITED Full time

Position: Regulatory Senior Consultant/ Consultant - CMC

Location: Hybrid (80 % remote, 20 % In office)

Reports To: Manager or above, Regulatory Affairs

unctional Responsibilities
- Work with global clients on regulatory filing projects for USFDA, EMA, MHRA, APAC, Canada etc. The key delivery areas include Pre and Post approval CMC authoring, preparation, and submission
- Scientific writing, review, and compilation of submission documents like quality overall summary (module 2), CMC quality - drug product, drug substance and regional information (module 3)
- Independently author and/or coordinate CMC activities for new registrations, post approval changes (minor, moderate and major), renewals, annual reports, and line extensions to meet filing requirements. Coordinating and contributing to responses to Agency queries and performing quality review of regulatory CMC submissions
- Deliver projects in either pharmaceutical / consumer products / Over the counter (OTC) drug products as per client portfolio/requirements
- Ensure timely delivery of error-free, high-quality CMC documents that meet international standards of written English and relevant technical requirements following internal/client-specific style guides/templates
- Demonstrate expertise at planning CMC submissions, including appropriate knowledge management tool

Skills and general profile
- Good understanding of global regulations USFDA, EMA, MHRA, APAC, TGA, etc.
- Strong working knowledge of electronic document and submission standards
- Excellent communication skills and effective in a collaborative team environment
- Advanced skills in the use of MS Word, Adobe Acrobat, Documentum systems
- Effective interpersonal skills
- Strong verbal and written English skills
- Ability to work in a fast-paced, cohesive, collaborative team-oriented work Environment
- Commitment to highest quality outputs, including meticulous attention to detail
- Enthusiasm and pro-activity

**Job Types**: Full-time, Permanent

**Salary**: ₹600,000.00 - ₹1,000,000.00 per month

**Benefits**:

- Health insurance
- Paid sick time
- Provident Fund
- Work from home

Schedule:

- Day shift
- Monday to Friday
- Weekend availability

Supplemental pay types:

- Performance bonus

**Experience**:

- total work: 4 years (preferred)

Work Location: In person



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