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
How Jobgether Works
We use an
AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
