ClinChoice Hiring Senior Associate – CMC5 Regulatory Affairs

ClinChoice Hiring Senior Associate – CMC Regulatory Affairs | BPharm, Chemistry | Bengaluru

ClinChoice is hiring for the position of Senior Associate – CMC5 in its Regulatory Affairs department at Bengaluru, India. This is a mid-to-senior level opportunity for professionals with experience in CMC regulatory affairs, particularly in preparing and reviewing Modules 2 and 3 for pharmaceutical product registrations. Candidates with strong exposure to EU and CIS regulatory filings, lifecycle management, and eCTD documentation are encouraged to apply.

This role is ideal for pharmacy and chemistry graduates who want to advance their careers in global regulatory submissions, CMC documentation, and pharmaceutical product lifecycle management within an international clinical research and regulatory consulting environment.

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Company Overview

ClinChoice is a global clinical research organization providing regulatory affairs, clinical operations, pharmacovigilance, and biometrics services to pharmaceutical and biotechnology companies. The organization supports sponsors across the full drug development lifecycle, from early development to post-approval maintenance and market expansion.

With strong expertise in regulatory consulting and global submission strategy, ClinChoice partners with clients to navigate complex health authority requirements across regions including Europe and CIS countries. The company focuses on quality, compliance, and strategic regulatory planning to accelerate product approvals while ensuring adherence to international pharmaceutical guidelines.

Working at ClinChoice offers professionals exposure to multinational regulatory projects, cross-functional collaboration, and evolving global compliance standards.

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Job Role & Responsibilities

The Senior Associate – CMC5 will play a key role in managing Chemistry, Manufacturing, and Controls (CMC) regulatory documentation and submissions for pharmaceutical products. The position requires deep knowledge of regulatory submission processes, technical writing, and global health authority interactions.

Core Responsibilities

• Manage preparation and submission of new product registrations and post-approval variations.
• Draft and review CMC Modules 2 and 3 in accordance with regulatory standards.
• Compile and review relevant Module 1 eCTD documentation.
• Coordinate responses to regulatory authority queries and follow submissions through approval.
• Oversee product lifecycle management activities, including variations and renewals.
• Ensure compliance with local and international regulatory requirements.
• Foster professional relationships with health authorities.
• Support regulatory strategy development aligned with business objectives.
• Provide regulatory support for new product launches, line extensions, and tender applications.
• Maintain regulatory tracking systems and documentation workflows to improve transparency and performance.
• Review formulation details, ingredient lists, and product claims for regulatory accuracy.
• Compile and review labeling components in accordance with internal SOPs and regional guidelines.
• Execute regional and local regulatory strategies within defined timelines.
• Ensure adherence to submission deadlines and quality standards.

This role demands strong project management skills, precision in documentation, and the ability to manage multiple regulatory submissions simultaneously.

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Eligibility & Qualifications

Educational Background

Minimum qualification: Bachelor’s degree in Chemistry, Pharmacy, or related scientific field.

Eligible qualifications include:
B.Pharm, M.Pharm, BSc Chemistry, MSc Chemistry, Pharmaceutical Chemistry, Industrial Pharmacy, Pharmaceutics, Regulatory Affairs, Biotechnology, Life Sciences, or related scientific disciplines.

Experience & Skills Required

• Proven experience in CMC Regulatory Affairs for pharmaceutical products.
• Hands-on experience preparing Module 3, Module 2.3, and relevant Module 1 eCTD documentation.
• Exposure to EU and CIS regulatory filing requirements.
• Strong understanding of EU pharmaceutical guidelines and their practical interpretation.
• Experience managing post-approval submissions and lifecycle maintenance.
• Ability to work independently and manage multiple projects.
• Strong written and verbal communication skills.
• Excellent attention to detail and documentation accuracy.
• Effective project management and cross-functional coordination skills.

Candidates with prior experience interacting with health authorities and managing end-to-end submission processes will be particularly well-suited for this role.

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Location & Employment Details

• Location: Bengaluru, India
• Employment Type: Full-Time
• Work Model: Remote/Hybrid as per business requirements

Application Process

Interested candidates can apply through the official ClinChoice career portal using the link below:

Apply Here: https://job-boards.eu.greenhouse.io/clinchoice/jobs/4660529101?source=LI

Applicants are encouraged to highlight their CMC module writing experience, EU regulatory exposure, and lifecycle management expertise in their resumes.

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Frequently Asked Questions (FAQs)

1. Is experience in EU filings mandatory?

Yes, exposure to EU regulatory filings is highly preferred for this role.

2. Which CMC modules will be handled?

The role focuses primarily on Modules 2 and 3, along with relevant Module 1 eCTD documentation.

3. Is prior lifecycle management experience required?

Yes, experience managing post-approval submissions and product lifecycle activities is expected.

4. What career growth can be expected?

Professionals can advance into Regulatory Affairs Manager, CMC Lead, or Global Regulatory Strategy roles.

5. Does the role involve interaction with health authorities?

Yes, maintaining professional communication with regulatory authorities is part of the responsibilities.

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Summary Table

Company	ClinChoice
Vacancies	Senior Associate – CMC5
Required Education	B.Pharm, M.Pharm, BSc/MSc Chemistry, Pharmaceutical Chemistry, Industrial Pharmacy, Regulatory Affairs, Biotechnology, Life Sciences
Experience	Experience in CMC Regulatory Affairs with EU filing exposure

Tagged as: Pharma Jobs in Bangalore