Regulatory Submissions Manager
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Submissions Manager in India.
This role is a key leadership position within regulatory affairs, focused on driving end-to-end regulatory submissions across global drug development programs. You will oversee critical filings such as CTA, IND, and MAA while ensuring compliance with evolving global regulatory standards. The position plays an important role in enabling timely development and approval of new therapies by providing strategic regulatory guidance and operational execution support. You will collaborate closely with cross-functional teams including clinical, medical, and development stakeholders to ensure high-quality submissions. The role requires strong ownership of regulatory processes, with the ability to operate independently while contributing to broader best practices. This is a highly impactful environment where precision, scientific understanding, and regulatory expertise directly influence patient access to innovative treatments.
Accountabilities:
- Lead and independently manage regulatory submission activities, including CTA, IND, MAA, and related filings across global development programs.
- Provide expert regulatory guidance to internal teams across clinical development, operations, and cross-functional stakeholders.
- Support and participate in regulatory agency interactions, ensuring accurate documentation and strategic alignment.
- Oversee preparation, review, and submission of high-quality regulatory dossiers in compliance with global requirements.
- Contribute to the development and continuous improvement of regulatory best practices, processes, and internal standards.
- Collaborate within cross-functional or program-specific teams to ensure alignment on submission strategies and timelines.
- Ensure compliance with global regulatory guidelines and support lifecycle management activities post-approval where required.
Requirements:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
- 6+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Proven experience managing regulatory submissions such as CTA, IND, and MAA independently.
- Strong understanding of global regulatory frameworks, guidelines, and submission processes.
- Ability to lead regulatory activities and collaborate effectively within cross-functional teams.
- Strong analytical thinking with attention to detail and ability to manage complex documentation.
- Excellent communication and stakeholder management skills in a global environment.
- Ability to work independently, prioritize tasks, and manage multiple regulatory deadlines.
Benefits:
- Competitive base salary with performance-based incentives
- Comprehensive health coverage including medical, dental, and vision (where applicable)
- Retirement and pension benefits
- Life assurance and disability protection coverage
- Employee assistance and wellbeing support programs
- Structured learning and development programs with clear career progression pathways
- Opportunity to work on global clinical development programs and innovative therapies
- Inclusive and collaborative work environment focused on professional growth
