ClinChoice Hiring Senior Associate CMC Regulatory Affairs Bengaluru pharma regulatory jobs with EU filing experience apply online 2026 opportunity.
ClinChoice has announced a new opportunity for experienced regulatory professionals to join its Regulatory Affairs team in Bengaluru. The company is hiring a Senior Associate – CMC (Chemistry, Manufacturing, and Controls) to support global pharmaceutical submissions and lifecycle regulatory activities. This position is ideal for candidates with prior experience in CMC documentation, EU regulatory filings, and international submission frameworks.
Professionals aiming to build long-term careers in global regulatory affairs and technical submission management can explore this role. With exposure to multinational projects and complex regulatory environments, this opportunity offers strong career progression in regulatory consulting and CRO domains. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Company Overview
ClinChoice is a global clinical research and regulatory consulting organization that supports pharmaceutical, biotechnology, and medical device companies across the drug development lifecycle. The company provides services in regulatory affairs, clinical operations, pharmacovigilance, and biometrics. With a global footprint and multinational client base, ClinChoice assists sponsors in navigating complex regulatory landscapes across regions including Europe and CIS markets.
The organization is known for delivering regulatory expertise aligned with international compliance standards while enabling faster product approvals and lifecycle management.
Job Location & Employment Type
- Location: Bengaluru, India
- Employment Type: Full-time
- Department: Regulatory Affairs – CMC
- Work Model: Hybrid or flexible work model (as per business needs)
This role is suited for mid-to-senior regulatory professionals with hands-on submission experience.
Job Role Overview
The Senior Associate – CMC will be responsible for preparing and managing regulatory submissions related to Chemistry, Manufacturing, and Controls documentation. The role involves working on new registrations, post-approval variations, and lifecycle regulatory activities for pharmaceutical products across global markets.
Candidates with expertise in Modules 2 and 3 writing, eCTD documentation, and regulatory compliance will be particularly suitable for this position. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Key Roles & Responsibilities
- Preparing and reviewing CMC sections of regulatory submissions
- Drafting and compiling Modules 2 and 3 in line with global guidelines
- Supporting Module 1 documentation within eCTD formats
- Managing post-approval changes, renewals, and lifecycle submissions
- Coordinating responses to regulatory authority queries
- Ensuring compliance with international regulatory requirements
- Supporting regulatory strategies for product launches and variations
- Maintaining regulatory tracking systems and submission documentation
- Reviewing formulation and labeling details for compliance accuracy
- Collaborating with cross-functional teams across global projects
This role requires strong attention to detail, structured documentation skills, and the ability to manage multiple submissions simultaneously. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Eligibility Criteria
Educational Qualification
Candidates must hold a degree in a relevant scientific discipline, such as:
- B.Pharm / M.Pharm
- B.Sc / M.Sc (Chemistry or related fields)
- Pharmaceutical Chemistry
- Industrial Pharmacy
- Regulatory Affairs
- Biotechnology or Life Sciences
Candidates with strong academic backgrounds in pharmacy or chemistry are preferred.
Experience
- Proven experience in CMC Regulatory Affairs
- Hands-on experience with Modules 2 and 3 documentation
- Exposure to eCTD submissions and lifecycle management
- Experience in EU regulatory filings preferred
- Understanding of global regulatory submission frameworks
Candidates with prior end-to-end submission ownership will have an advantage.
Skills Required
- Strong regulatory writing and documentation skills
- Knowledge of international regulatory requirements
- Experience with post-approval lifecycle management
- Ability to manage multiple regulatory projects
- Strong analytical and communication skills
- Project management and coordination abilities
Exposure to health authority interactions is beneficial for this role. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Salary & Benefits
- Compensation will be as per company norms and experience level
- Opportunity to work on global regulatory projects
- Exposure to multinational pharmaceutical clients
- Career growth in regulatory consulting and CRO sectors
- Learning opportunities in global submission strategies
This role offers long-term growth potential for professionals targeting global regulatory careers. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Selection Process
The hiring process may include:
- Resume screening based on regulatory experience
- Technical discussion focusing on CMC documentation expertise
- Final HR or leadership interaction
Candidates with strong EU filing experience and structured regulatory exposure may be prioritized.
How to Apply
Interested candidates can apply through the official application link below:
While applying, ensure your resume highlights:
- CMC module writing experience
- eCTD submission exposure
- EU or global regulatory filing experience
- Lifecycle management involvement
Well-structured regulatory resumes may improve shortlisting chances.
Important Dates
- Job Posted: February 2026
- Application Mode: Online application
- Hiring Type: Immediate or ongoing recruitment
Candidates are encouraged to apply early as regulatory roles may close after suitable hiring. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Why Apply for This Pharma Job?
Regulatory Affairs remains one of the most specialized and globally relevant career paths in the pharmaceutical industry. This opportunity at ClinChoice allows professionals to work on international regulatory submissions, particularly within EU-focused markets. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Exposure to CMC modules and global regulatory documentation enhances long-term career prospects, especially for professionals aiming to transition into leadership roles such as Regulatory Managers or Global Submission Leads. Working in a regulatory consulting organization also provides diverse project exposure compared to single-product environments.
For professionals with prior regulatory experience, this role offers an opportunity to expand expertise in lifecycle management, international submissions, and cross-regional regulatory strategy. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Important Note
IndiaPharmaJobs.in is an independent pharmaceutical job information platform and is not affiliated with ClinChoice. We do not participate in the recruitment process. Applicants should apply through the official link provided and verify job details independently before proceeding. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
Final Words
If you are an experienced regulatory professional looking to advance your career in global pharmaceutical submissions, this opportunity at ClinChoice is worth considering. With a focus on CMC regulatory affairs, EU filings, and lifecycle management, the role offers exposure to international projects and long-term growth potential. Interested candidates should apply online and ensure their resumes reflect relevant regulatory expertise for better shortlisting chances. ClinChoice Hiring Senior Associate CMC Regulatory Affairs
