Regulatory Affairs Specialist | ClinChoice Hyderabad

ClinChoice Hyderabad is hiring Regulatory Affairs Specialists with CMC & e-CTD experience. Apply now to manage EU & CIS regulatory submissions.

---

ClinChoice is seeking a Regulatory Affairs Specialist to join its Hyderabad office. This role offers the opportunity to manage end-to-end regulatory submissions, oversee product registrations, life cycle management, and ensure compliance with EU and CIS regulations.

---

Company Overview

ClinChoice is a leading pharmaceutical organization committed to regulatory excellence, product compliance, and global healthcare innovation. The company focuses on efficient product registration, timely approvals, and adherence to international standards, empowering its regulatory team to make a significant impact on healthcare delivery.

---

Job Role & Responsibilities

As a Regulatory Affairs Specialist, your responsibilities include:

• Preparing and submitting CMC modules (2 & 3) and post-approval filings.
• Supporting product launches and tender applications.
• Coordinating with health authorities to ensure compliance with regulations.
• Reviewing formulations, claims, and labeling in accordance with company SOPs.
• Managing timelines and project deliverables for regulatory submissions.

---

Eligibility / Qualifications

• Education: Degree in Chemistry, Pharmacy, or a related field.
• Experience: Hands-on experience in CMC regulatory affairs and e-CTD documentation.
• Skills: Strong project management, communication, and coordination skills.

Relevant courses include: BPharm, MPharm, MSc Chemistry, MSc Pharmaceutical Sciences, Regulatory Affairs Certification.

---

Location & Work Mode

• Location: Hyderabad, India
• Work Mode: Full-time, Work from Office

---

Application Process

Interested candidates are invited to share their CV with ClinChoice at:

• Email: saba.naaz@clinchoice.com

Apply now to become part of a team that drives regulatory excellence and global compliance in pharmaceuticals.

---

FAQs

1. Who can apply?
Candidates with a degree in Chemistry, Pharmacy, or related fields, and experience in CMC regulatory affairs.

2. What are the responsibilities?
Preparation and submission of CMC modules, product launches, coordination with health authorities, and compliance management.

3. Where is the position located?
Hyderabad, India (Work from Office).

4. Is prior experience required?
Yes, experience in CMC regulatory affairs and e-CTD documentation is necessary.

5. How to apply?
Send your CV to saba.naaz@clinchoice.com.

---

Job Summary Table

Category	Details
Company	ClinChoice
Vacancies	Regulatory Affairs Specialist
Required Education	BPharm, MPharm, MSc Chemistry, MSc Pharmaceutical Sciences, Regulatory Affairs Certification
Experience	Experience in CMC regulatory affairs & e-CTD documentation
Location	Hyderabad, India