Associate Senior Associate Regulatory Affairs Bengaluru Pharma Jobs at ClinChoice for FDA submissions, NDC management, and pharma lifecycle compliance.
Company Overview
ClinChoice is a globally recognized life sciences services organization supporting pharmaceutical, medical device, and consumer healthcare companies across regulatory and clinical functions. With a strong foundation built over multiple decades, the organization partners with innovators worldwide to manage complex regulatory requirements, ensure compliance, and support product commercialization across global markets. Its presence in multiple countries allows regulatory professionals in India to work on international submissions while gaining exposure to global regulatory frameworks and best practices. Associate Senior Associate Regulatory Affairs
Job Location & Employment Type
- Job Location: Bengaluru, Karnataka, India
- Work Mode: Office-based (Onsite)
- Employment Type: Full-Time | Permanent
- Functional Area: Regulatory Affairs – Drug Listing & Lifecycle Management
Open Positions / Department Details
- Position Title: Associate / Senior Associate – Regulatory Affairs (Drug Listing)
- Department: Regulatory Affairs – Pharmaceuticals
- Experience Range: 2 to 4 Years
This position is suitable for regulatory professionals with hands-on experience in FDA drug listing, regulatory documentation, and lifecycle management activities for pharmaceutical products, particularly within the North American regulatory landscape. Associate Senior Associate Regulatory Affairs
Key Roles & Responsibilities
Primary Responsibilities
The selected candidate will be responsible for managing regulatory operations related to drug listing and FDA submissions while ensuring full compliance with applicable regulations and internal procedures. Associate Senior Associate Regulatory Affairs
- Execute end-to-end drug product lifecycle management activities for pharmaceutical products intended for the North American market.
- Prepare, compile, coordinate, and support regulatory submissions to the US FDA for new product launches, post-approval changes, and ongoing lifecycle updates.
- Author, review, and submit Drug Listing (DL) documentation in alignment with regulatory requirements and internal SOPs.
- Evaluate product data and assign National Drug Codes (NDCs) for bulk drug substances and finished dosage forms in accordance with FDA regulations.
- Maintain accurate NDC records and ensure timely updates to drug listing information as required by regulatory changes or product modifications.
- Review, assess, and manage change controls related to drug listing, labeling, packaging, and other regulatory-impacting activities.
- Ensure all regulatory submissions are accurate, complete, and delivered within defined timelines to avoid compliance risks.
- Monitor regulatory compliance status and proactively identify potential gaps or issues that may impact product registration or maintenance.
Secondary Responsibilities
In addition to core drug listing activities, the role involves supporting broader regulatory operations and documentation management. Associate Senior Associate Regulatory Affairs
- Upload, route, archive, and maintain regulatory documentation within internal electronic systems such as CEDMS, DSP/cMAT, Reg Point, and SharePoint.
- Update and manage controlled documents including SOPs, investigations, CAPAs, corrections, and related records in electronic document management systems.
- Support Annual Product Registration, Establishment Registration, and renewal activities in line with FDA expectations.
- Track change control deliverables, monitor progress, and ensure timely closure of regulatory action items.
- Initiate extension requests or escalation processes when timelines cannot be met due to operational or regulatory constraints.
- Communicate project milestones, submission status, and regulatory risks clearly to internal stakeholders and management teams.
- Act as a project coordinator or lead when required by scheduling meetings, aligning cross-functional teams, and driving on-time completion of drug listing activities.
- Maintain audit readiness by ensuring all regulatory records are current, traceable, and compliant with internal and external requirements.
Eligibility Criteria
Education
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline is preferred.
Experience
- 2 to 4 years of relevant experience in Regulatory Affairs, Quality Assurance, Packaging, or Labeling within the pharmaceutical industry.
- Hands-on exposure to FDA submissions, drug listing processes, and regulatory documentation is required.
- Experience supporting North American regulatory activities will be considered an advantage.
Skills Required
- Strong understanding of US FDA drug listing regulations and lifecycle management requirements.
- Working knowledge of NDC assignment processes for pharmaceutical products.
- Familiarity with regulatory document management systems and electronic submission platforms.
- Excellent organizational skills with a high level of attention to detail and compliance accuracy.
- Ability to manage multiple tasks, prioritize deliverables, and meet regulatory timelines consistently.
- Strong written and verbal communication skills to coordinate with cross-functional teams and stakeholders.
- Proficiency in standard office tools such as Microsoft Word, Excel, and PowerPoint.
Associate Senior Associate Regulatory Affairs
Salary & Benefits
- Salary: As per company norms
- Additional benefits will be provided according to company policies and role eligibility.
Selection Process
- Initial application screening
- Technical and regulatory interview rounds
- HR discussion and final selection
The process may vary depending on project requirements and organizational needs. Associate Senior Associate Regulatory Affairs
How to Apply
Eligible candidates can apply through the online application process as specified in the official job posting.
Important Dates
- Application timelines are subject to change based on business requirements.
- Candidates are encouraged to apply at the earliest for better consideration.
Why Apply for This Pharma Job?
This role offers an excellent opportunity to build expertise in FDA drug listing and regulatory lifecycle management while working in a structured, compliance-driven environment. Professionals will gain direct exposure to North American regulatory processes, collaborate with experienced regulatory teams, and strengthen their long-term career prospects in pharmaceutical regulatory affairs. The onsite Bengaluru location provides a stable work environment with opportunities for skill enhancement and career growth. Associate Senior Associate Regulatory Affairs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform. We are not associated with any pharmaceutical company or recruitment agency. All job-related information is shared for informational purposes only. Candidates should verify details from official sources before applying. Associate Senior Associate Regulatory Affairs
Final Call-to-Action
If you have experience in FDA drug listing and regulatory documentation and are seeking a stable pharma regulatory career, apply now and take the next step forward. Associate Senior Associate Regulatory Affairs
