Senior Associate Jobs at ClinChoice | BSc Chemistry Graduates Apply Now
Are you looking for senior associate jobs, opportunities in ClinChoice careers, or a specialized BSc chemistry job in pharmaceutical regulatory affairs? The Senior Associate – CMC5 position in Bengaluru offers an exceptional role for experienced professionals skilled in CMC documentation, global regulatory submissions, and life-cycle management. This role is ideal for candidates seeking growth in regulatory affairs with strong exposure to EU and CIS markets, CMC Modules 2 and 3, and advanced compliance frameworks.
About ClinChoice
ClinChoice is a global clinical research and regulatory services provider known for delivering high-quality, compliant, and efficient solutions to the pharmaceutical and life-science sectors. With strong operational capabilities and a people-first culture, ClinChoice offers excellent growth pathways for professionals seeking senior associate jobs, regulatory roles, and specialized BSc chemistry job opportunities. Through ClinChoice careers, talented individuals can grow, contribute to global healthcare advancements, and work on cutting-edge research and development programs.
Details
- Job Title: Senior Associate – CMC5
- Location: Bengaluru, India
Qualifications and Desired Skills:
- Minimum B.S. Chemistry, Pharmacy, or related scientific field.
- Experience in CMC regulatory affairs for pharmaceutical products.
- Experience in Module 3, Module 2, and Module 3, and relevant Module 1 e-CTD documentation.
- Ability to multitask effectively and work independently in a remote setting.
- Attention to detail.
- Excellent written and verbal communication skills.
- Project management skills.
- Familiarity with EU pharmaceutical guidelines and their interpretation.
Primary Responsibilities:
- Manage the preparation and submission of new product registrations, post approval submission, and follow up closely on queries and through approval.
- Responsible for writing CMC modules – 2 & 3.
- Exposure to the EU & CIS region in Regulatory filings.
- Manage and coordinate product life cycle management.
- Ensure regulatory compliance with local regulatory requirements.
- Foster and maintain professional relationships with the health authorities.
- Provide regulatory support, including timely registration of new products and line extensions to support new product launches, tender applications, and whenever necessary.
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
- Promote regulatory intelligence in both local and regional initiatives.
- Development of regulatory strategies, preparation of regulatory applications, and support maintenance activities within the relevant therapy area.
- Responsible for reviewing CMC modules.
- Execution of regulatory strategies (local and regional) in line with the business plan.
- Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
- Ensure adherence to timelines and quality set parameters.
- Review of Formulation, generation of ingredient list, and Claims as per set standards.
- Compilation and review of labeling components as per SOP.
