Medreich is seeking talented Regulatory Associates and Specialists with 2-8 years of relevant experience in pharmaceutical regulatory affairs, particularly with finished formulations and OSD. These regulatory associate jobs involve managing the compilation and submission of documents to global markets, ensuring compliance with stringent regulatory requirements.
Key Responsibilities in Pharmaceutical Regulatory Specialist Positions:
- Compile and Coordinate Submissions: Gather and prepare CTD dossier modules for new applications, post-approval changes, variations, and lifecycle management activities. Work closely with teams to meet deadlines for markets including the EU, UK, New Zealand, CIS, GCC, ASEAN, and LATAM.
- Regulatory Strategy Development: Develop and implement strategies for Marketing Authorization Applications (MAAs), ensuring alignment with global regulatory guidelines.
- Deficiency Management: Interpret and prepare responses to quality and administrative deficiencies, maintaining accuracy within defined timelines.
- Cross-Functional Collaboration: Coordinate with internal teams to request, review, and finalize documentation for submissions. Ensure thorough reviews before final regulatory submissions.
- Global Market Expertise: Gain experience in pharmaceutical regulatory submissions across diverse regions, focusing on compliance and efficiency.
These regulatory affairs jobs in Bengaluru require strong attention to detail, knowledge of regulatory frameworks, and the ability to operate in a fast-paced corporate office setting. Ideal candidates will have a background in pharma regulatory compliance and a drive to support innovative drug development.
Requirements for Regulatory Associate Jobs:
- 2-8 years of experience in pharmaceutical regulatory affairs with finished formulations/OSD.
- Proficiency in CTD modules, regulatory guidelines, and global submission processes.
- Excellent communication and coordination skills for team-based projects.
- Location: Corporate office in Bengaluru (onsite role).
If you’re looking for pharmaceutical regulatory specialist careers that offer growth and impact, Medreich’s regulatory associate jobs provide the perfect platform.
About Medreich: A Leader in Pharmaceutical Innovation
Medreich is a prominent name in the global pharmaceutical industry, specializing in high-quality generics, biosimilars, and specialty pharmaceuticals. With a commitment to innovation and regulatory excellence, Medreich serves markets worldwide, including emerging regions like LATAM and ASEAN. The company emphasizes ethical practices, cutting-edge research, and sustainable healthcare solutions.
As part of Medreich careers, you’ll join a team dedicated to advancing pharmaceutical regulatory compliance. Founded with a vision to make medicines accessible, Medreich has grown into a trusted partner for regulatory affairs jobs, offering opportunities for professional development in a supportive environment. Learn more about our mission and openings on our website, Pharmabharat.org, where we regularly post pharmaceutical jobs and industry insights.
How to Apply for Regulatory Associate Jobs at Medreich
Ready to apply for these pharmaceutical regulatory specialist positions? Send your resume and cover letter to aravinda.p@medreich.com or swathi.ds@medreich.com. Highlight your experience in regulatory submissions, global markets, and pharma compliance to stand out.