Job Title : RA Specialist

Department : Regulatory Affairs

Qualification : B.Pharm / M.Pharm

Experience : 3 to 7 Years

Location : Patas, Pune

JOB DESCRIPTION

1. Develop and execute submission strategies for new product approvals, clinical trials (IND/CTA), and lifecycle maintenance (NDAs, ANDAs, 510(k), PMAs, or technical dossiers).

2. Communicate directly with regulatory agencies to track submission progress, answer queries, and negotiate approvals without undue delay.

3. Review product packaging, patient information leaflets (PIL), Summary of Product Characteristics (SmPC), and promotional or marketing materials.

4. Evaluate manufacturing, design, or formulation changes to determine if supplemental or amended regulatory filings are required.

5. Support or host regulatory inspections, internal quality/compliance audits, and CAPA (Corrective and Preventive Action) resolutions.

6.



Track updates in global regulatory guidelines (e.g., ISO standards, cGMP, ICH) and assess their impact on existing company portfolios.

KEY SKILLS & COMPETENCIES

1. Deep understanding of Common Technical Document (CTD) formats and regional regulatory frameworks (FDA, EU-MDR/CE, CDSCO, etc.).

2. Robust technical writing, documentation precision, and attention to detail.

3. Analytical mindset with the ability to interpret dense legal/scientific texts.

4. Cross-functional collaboration across R&D;, Quality Assurance (QA), Clinical Research, and Commercial/Marketing teams.

5. Effective verbal and written communication in English.

Pay: ₹20,000.00 - ₹30,000.00 per month

Benefits:

- Provident Fund

Work Location: In person

📌 RA Specialist (Patas)
🏢 Steribio Lifesciences Private
📍 Patas