The pharmaceutical and life sciences industry is evolving rapidly, with stricter global regulations demanding expert navigation of complex submission processes. UsefulBI Corporation, a premier AI-driven data solutions provider serving Fortune 500 clients, is expanding its team to support innovative work in this critical area.
We are hiring a Regulatory Affairs Specialist (SME) based in Bengaluru, Karnataka, India. This role offers the chance to shape regulatory strategies for pharmaceutical products, collaborating with multidisciplinary teams to drive compliance and successful submissions worldwide.
If you have deep expertise in regulatory affairs within pharma or life sciences, particularly in global and regional requirements, this position at UsefulBI provides a platform to make a meaningful impact.
Roles & Responsibilities
As a Regulatory Affairs Specialist, you will serve as the go-to expert for regulatory compliance and submissions. Your core duties include:
- Delivering subject matter expertise on global and regional regulatory requirements and associated submissions.
- Applying in-depth knowledge of CMC (Chemistry, Manufacturing, and Controls) requirements and their influence on regulatory filings.
- Reviewing and interpreting evolving regulatory guidelines to guide product development and lifecycle management.
- Collaborating closely with cross-functional teams—including clinical, CMC, medical, and quality—to maintain full compliance with health authority regulations.
- Preparing, reviewing, and maintaining key regulatory documents such as INDs, NDAs, MAAs, CTDs, and other submissions to agencies.
- Supporting timely responses to health authority queries and participating in regulatory audits.
- Monitoring and implementing updates to regulatory frameworks that affect current and upcoming submissions.
Required Qualifications & Skills
The ideal candidate brings proven experience and technical proficiency in regulatory affairs. Key requirements include:
- 7+ years of hands-on experience in Regulatory Affairs within the pharmaceutical or life sciences sector.
- 5+ years of direct experience with Marketing Authorization Applications (MAAs).
- 5+ years working with Electronic Common Technical Document (eCTD) submissions and related tools.
- Strong knowledge of global regulatory processes, including USFDA, EMA, CDSCO, and other major authorities.
- Practical experience in eCTD submissions and developing effective regulatory strategies.
- Excellent analytical skills, meticulous documentation abilities, and strong communication (both written and verbal).
Candidates with 5–8 years of overall relevant experience are encouraged to apply, with emphasis on those meeting or exceeding the specified thresholds in MAAs and eCTD.
Salary, Benefits & How to Apply
UsefulBI offers a competitive compensation package tailored to attract top regulatory talent in Bengaluru’s thriving life sciences ecosystem. The salary range for this Regulatory Affairs Specialist role is ₹12,00,000 – ₹22,00,000 per annum (depending on experience, skills, and negotiation). Additional benefits typically include performance bonuses, health insurance, professional development opportunities, flexible work options, and more.
To apply, visit the UsefulBI careers page or send your updated CV with a cover letter highlighting your regulatory submissions experience to their official HR contact (details available on usefulbi.com). Mention “Regulatory Affairs Specialist – Bengaluru” in the subject line.
