Rusan Pharma Hiring Regulatory Affairs

Regulatory Affairs Roles – Rusan Pharma | 5–10 Years Exp

Rusan Pharma hiring Regulatory Affairs professionals for CIS, India, Canada & ANZ markets. Openings for 5–10 yrs experience.

Rusan Pharma is hiring experienced Regulatory Affairs professionals for multiple global market portfolios including CIS, India (CDSCO), Canada and ANZ. These openings suit candidates with strong dossier preparation capability, regulatory query handling experience and hands-on exposure to market‑specific guidelines. The roles offer a chance to work within a global regulatory environment supported by structured documentation systems and scientific teams.

Company Overview

Rusan Pharma is a leading pharmaceutical organization with a strong presence across regulated and semi‑regulated markets. The company focuses on therapeutic innovation, robust regulatory strategies and high‑compliance manufacturing. With an expanding portfolio, Rusan provides opportunities to work closely with cross‑functional teams, regulatory consultants and international Health Authorities.

Job Role & Responsibilities

1. Assistant Manager – CIS Market (8–10 Years)

• Manage regulatory submissions for CIS regions including Russia, Ukraine, Uzbekistan and Kazakhstan.
• Prepare dossiers in line with updated CIS/EAEU guidelines.
• Handle regulatory queries and execute corrective actions.
• Coordinate with CFTs for timely submission and approval.

2. Executive / Sr. Executive – India Market (CDSCO) (5–7 Years)

• Prepare dossiers as per SUGAM and CDSCO requirements.
• Manage portal submissions, licensing documentation and regulatory query responses.
• Ensure compliance with updated Indian regulatory frameworks.

3. Executive / Sr. Executive – Canada & ANZ Market (5–7 Years)

• Compile regulatory submissions for Canada and ANZ as per regional guidelines.
• Prepare and update technical dossiers for regulatory review.
• Coordinate timely response to HA queries and maintain documentation accuracy.

4. Sr. Executive – Regulatory Analytical (7–8 Years) (Male Preferred)

• Work closely with QC and analytical teams to resolve regulatory quality queries.
• Support method validation, protocol preparation and analytical documentation.
• Provide on‑site support during regulatory reviews and data verification.
• Travel to facilities when required.

Eligibility / Qualifications

Required Education

• B.Pharm, M.Pharm, M.Sc (Chemistry, Analytical, Regulatory Sciences)

Relevant Courses

Regulatory Affairs, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Method Validation, Drug Development.

Experience Requirements

• CIS Market: 8–10 years
• India CDSCO: 5–7 years
• Canada & ANZ: 5–7 years
• Regulatory Analytical: 7–8 years

Location & Salary

These are regional regulatory roles; location details will be shared by Rusan Pharma during the selection process. Salary will be based on experience, regulatory exposure and market responsibility.

Application Process

Interested candidates can send their updated CV to:
namrata.mishra@rusanpharma.com

Include details of market experience, dossier types handled and query management expertise.

FAQs

1. Are these roles suitable for freshers?
No. All positions require 5–10 years of regulatory experience.

2. Is CIS experience mandatory for the Assistant Manager role?
Yes. Only candidates with proven CIS/EAEU regulatory experience will be considered.

3. Are analytical candidates required to travel?
Yes. The Regulatory Analytical role may require visits to QC/QA facilities.

4. Is SUGAM portal experience mandatory for India‑market roles?
Yes. Hands‑on experience with CDSCO/SUGAM submissions is essential.

5. Do these roles involve international communication?
Yes. Candidates must be comfortable interacting with overseas consultants and Health Authorities.

Summary Table

Category	Details
Company	Rusan Pharma
Vacancies	Regulatory Affairs – CIS, India, Canada, ANZ; Regulatory Analytical
Required Education	B.Pharm, M.Pharm, M.Sc
Experience	5–10 years depending on role