Job Title: Regulatory Affairs Specialist – CMC (Remote – India)
Summary:
Are you a Regulatory Affairs professional with a strong background in CMC (Chemistry, Manufacturing, and Controls) submissions? We’re seeking a highly motivated Regulatory Affairs Specialist to join our dynamic team and contribute to global regulatory success. This remote role offers an exciting opportunity to work on a variety of regulatory submissions, collaborate with cross-functional teams, and develop your skills in a fast-paced environment. If you have a passion for regulatory compliance, a keen eye for detail, and experience with RIMS and eDMS systems, we encourage you to apply!
About the Role:
As a Regulatory Affairs Specialist – CMC, you will play a vital role in ensuring our pharmaceutical products meet the necessary regulatory requirements for global markets. You will be responsible for preparing, authoring, and managing CMC-related submissions, ensuring compliance with GMP guidelines, and maintaining our internal regulatory systems. This position offers a unique opportunity to contribute to the success of our products while working remotely from anywhere in India.
Key Responsibilities:
- Prepare and author global CMC variation submissions, renewals, annual reports, tender applications, and GMP submissions.
- Ensure compliance with client submission timelines and technical requirements.
- Provide regulatory packages for internal review and manage updates as required.
- Finalize submission packages for publishing and QA review.
- Maintain and update internal systems including RIMS (Regulatory Information Management System), eDMS (Electronic Document Management System), and change management tools.
- Respond to queries from partners and global health authorities.
- Collaborate cross-functionally across departments and regulatory partners (e.g., technical, quality, and compliance teams).
- Identify out-of-scope contract activities and support modifications.
Required Qualifications:
- Education: Bachelor’s or Master’s degree in Life Sciences or a relevant health science field. A degree in Regulatory Affairs is considered an advantage.
- Experience: A minimum of 2 years of experience in Regulatory Affairs CMC within the biotechnology or pharmaceutical industry.
- Domain Skills: Experience with biologics, vaccines, gene therapy, or small molecules is preferred.
- Knowledge: A strong understanding of GMP (Good Manufacturing Practice) guidelines and regulatory compliance is essential.
Technical Skills:
- Hands-on experience with:
- RIMS (e.g., Veeva RIMS)
- eDMS platforms (e.g., Veeva, Documentum)
- TrackWise or similar Change Management systems
- Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and excellent documentation writing skills.
Competencies:
- Excellent written and verbal communication skills, with the ability to clearly articulate regulatory requirements and technical information.
- Strong organizational and time-management skills, with the ability to prioritize tasks, meet deadlines, and manage multiple projects simultaneously.
- Ability to work independently with minimal supervision, demonstrating initiative and problem-solving skills.
- Adaptability to working with cross-cultural global teams and collaborating effectively with individuals from diverse backgrounds.
- Strong analytical and problem-solving mindset, with the ability to identify and address regulatory challenges proactively.
Benefits of Working in This Role:
- 100% Remote: Enjoy the flexibility of working from anywhere in India.
- Global Exposure: Gain exposure to global regulatory submissions and expand your knowledge of international regulatory landscapes.
- Skill Development: Develop your expertise in advanced regulatory systems and stay up-to-date with the latest regulatory trends.
- Cross-Cultural Collaboration: Collaborate with cross-cultural teams and broaden your professional network.
Job Location:
Remote — India
To Apply:
If you are a qualified and passionate Regulatory Affairs professional looking for an exciting opportunity, we encourage you to submit your application. We look forward to hearing from you!