Clinical Project Assistant
Sanofi
Advertisement
Job Description
Location: Chennai, India
Employment Type: Contract
Experience: 0–6 months
About the Role
Johnson & Johnson is seeking a Regulatory Affairs Associate to support regulatory compliance and documentation activities for formulations, raw materials, and product information. In this role, you will collaborate with local operating companies and cross-functional teams to ensure product data accuracy, adherence to global and regional regulatory standards, and timely documentation delivery.
This position offers a valuable opportunity to gain hands-on experience in regulatory affairs, product compliance, and raw material qualification, while contributing to global product innovation and market readiness.
Role & Responsibilities
- Collaborate with local operating companies to perform regulatory review and approval of formulations, raw materials, and constituent information.
- Verify and validate key formulation data, including:
- Trade name
- Manufacturer information
- INCI name
- CAS/EINECS number
- Constituent percentages
- Regional and global regulatory requirements
- Trade name
- Evaluate the impact of changes on regulatory compliance, documentation, and reporting obligations.
- Review formulations for new product development, innovation platforms, and marketed products to ensure compliance with local and J&J internal standards.
- Prepare, compile, and manage regulatory documentation in collaboration with cross-functional partners.
- Coordinate with Product Risk & Safety (PR&S) Designated Responsible Individuals (DRIs) to develop project implementation plans and track progress.
- Apply existing best practice documents and work instructions for raw material and formulation review processes.
Educational Qualification
- Education: Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Biotechnology, or a related discipline.
- Experience: 0–6 months in Regulatory Affairs, Quality Assurance, or Product Compliance (internship or academic project experience preferred).
- Skills Required:
- Strong understanding of regulatory guidelines and product compliance documentation.
- Attention to detail with analytical and problem-solving abilities.
- Excellent written and verbal communication skills.
- Proficiency in MS Office tools and data management systems.
- Strong understanding of regulatory guidelines and product compliance documentation.
- Ability to work effectively in a cross-functional and deadline-driven environment.
Location
Chennai, India
Advertisement
Clinical Research Associate 1
AstraZeneca
CTIS Administrator
Parexel
Clinical Research Associate (Level I, Level II & Sr. CRA)
Thermo Fisher Scientific
Associate Clinical Study Manager
Novartis
eClinical Coordinator
Medpace
Pharmacovigilance Services Associate
accenture
Associate – Regulatory Affairs
CLINCHOICE