Job Summary
We are seeking talented and motivated individuals to join our Regulatory Affairs team in India. We have three exciting opportunities available, ranging from entry-level to senior specialist positions. These roles offer the chance to contribute to regulatory submissions, ensure compliance, and advance your career in a dynamic, global environment. Both onsite and remote positions are available.
Job Summary
We are looking for highly skilled and motivated Regulatory Affairs professionals to join our expanding team in India. We have openings for a Principal Regulatory Affairs Assistant (onsite, Bangalore), a Regulatory Affairs Specialist (remote), and a Senior Regulatory Publishing Specialist (remote). These roles offer a fantastic opportunity to develop your skills and advance your career in a supportive and challenging environment. You will be involved in various aspects of regulatory affairs, from supporting EUCTR submissions to leading eCTD publishing activities.
Responsibilities
The specific responsibilities will vary depending on the position. However, common responsibilities across all roles include:
- Preparing and reviewing regulatory submissions in accordance with relevant guidelines and regulations.
- Ensuring compliance with applicable laws, regulations, and company policies.
- Maintaining accurate and up-to-date regulatory documentation.
- Collaborating with cross-functional teams to ensure timely and accurate submissions.
- Contributing to the development and improvement of regulatory processes.
- Staying current with changes in regulatory requirements and guidance.
- Managing documentation lifecycles.
- Communicating effectively with internal and external stakeholders.
Specific Role Responsibilities
- Principal Regulatory Affairs Assistant (Onsite – Bangalore): Support EUCTR documentation and regulatory submissions, maintain SOP awareness, coordinate project deliverables, and support bids and proposals.
- Regulatory Affairs Specialist (Remote – India): Support EUCTR submission processes, manage RIMS and document workflows, ensure compliance with agency and SOP requirements, and communicate with global project teams.
- Senior Regulatory Publishing Specialist (Remote – India): Prepare submission-ready dossiers per ICH/eCTD requirements, perform publishing quality review, work with Veeva Vault and Adobe, train team members, and manage high-complexity global submissions independently.
Requirements
The qualifications and experience required will vary depending on the specific role.
General Requirements:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Strong understanding of regulatory requirements and guidelines.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite.
Specific Role Requirements:
- Principal Regulatory Affairs Assistant: 1+ years of regulatory affairs or documentation experience.
- Regulatory Affairs Specialist: 2+ years of regulatory affairs experience, knowledge of RIMS, SOP alignment, and documentation auditing.
- Senior Regulatory Publishing Specialist: 5+ years of experience in regulatory publishing, expertise in eCTD, CSR, IB, modules, and document formatting.
Benefits of Joining
- Opportunity to work with a leading global CRO.
- Competitive salary and benefits package.
- Professional development and growth opportunities.
- Exposure to a diverse range of regulatory activities.
- Collaborative and supportive work environment.
- Opportunity to work remotely for eligible roles.
- Skill enhancement in EUCTR, eCTD, regulatory compliance, and relevant software tools.
How to Apply
Interested candidates are encouraged to apply for the specific role that aligns with their qualifications and experience.