Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist to join their PPD® clinical research services team. This position supports the preparation of regulatory documentation, ensuring compliance and facilitating the delivery of client projects within clinical research services. The role is key to advancing drug development and bringing innovative therapies to market.
Are you a detail-oriented scientific professional with a passion for ensuring regulatory compliance? Pharmabharat is excited to announce an opening for a Regulatory Affairs Specialist in Bangalore, Karnataka, with a leading global provider of chemicals and solutions for the life sciences industry. This is a fantastic opportunity to contribute to a company that is enabling scientists to make the world healthier, cleaner, and safer. If you have experience navigating the complex landscape of chemical regulations, particularly EU REACH and GHS, this could be the perfect role for you.
About the Company
Our client is a leading global player, providing a broad range of chemicals and solutions that support virtually every laboratory application. From cutting-edge research to drug discovery, development, and manufacturing, they empower scientists to bring chemistry to life. They are committed to innovation, quality, and regulatory excellence.
The Role: Regulatory Affairs Specialist
As a Regulatory Affairs Specialist, you will play a critical role in supporting the Life Sciences Product Compliance teams. Your primary responsibilities will involve coordinating responses to customer inquiries, managing regulated product assessments and orders, and ensuring adherence to global regulatory standards. This position is fully onsite in Bangalore.
Key Responsibilities:
- Customer Inquiry Management: Coordinate and manage customer inquiries related to chemical compliance, providing accurate and timely information.
- Product Compliance Review: Review chemical product compliance against pre-set criteria, ensuring alignment with regulatory requirements.
- End Use Declarations: Coordinate customer End Use Declarations, ensuring proper documentation and compliance.
- Regulated Order Management: Manage regulated orders, ensuring all necessary documentation and approvals are in place.
- Data Management: Maintain and update ERP systems with relevant regulatory information.
- EU REACH & GHS Expertise: Apply a strong understanding of EU REACH regulation, GHS (Globally Harmonized System), OSHA and compliance processes.
- Documentation Coordination: Coordinate REACH registration and Poison Center notification documentation.
- Collaboration: Work closely with customer service team members to ensure seamless support.
- Regulatory Adherence: Ensure the organization’s products adhere to global regulatory standards.
- Teamwork: Effectively collaborate and coordinate activities with fellow team members.
Qualifications and Experience:
- Equivalent experience in a scientific environment or a Master’s degree in a natural science or chemistry.
- 4 – 6 years of experience in Regulatory Affairs. Certification in Regulatory Affairs is a plus.
Skills and Abilities:
- Communication Skills: Excellent written and verbal communication skills, with the ability to communicate clearly and effectively across various channels.
- Regulatory Knowledge: Strong understanding of EU REACH regulation, GHS, OSHA, and compliance processes.
- Technical Proficiency: Proficiency with regulatory submission software and data management systems.
- Interpersonal Skills: Strong interpersonal skills, including the ability to remain calm, professional, and positive under pressure.
- Teamwork: Ability to work effectively as a member of a team in a fast-paced environment.
- Organizational Skills: Highly motivated, possessing strong organizational skills, and able to prioritize multiple activities concurrently.
- Analytical Skills: The ability to critically analyze safety data sheets (SDS) and communicate the applicable regulatory information.
