Medreich Hiring Regulatory Associates & Specialists

Regulatory Associate & Specialist – Pharma – Bengaluru

Medreich Limited hiring Regulatory Associates & Specialists (2-8 yrs) for pharmaceutical OSD/formulations. Apply in Bengaluru for global regulatory submissions.

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Join Medreich Limited, a leading pharmaceutical organization, as a Regulatory Associate or Specialist and be at the forefront of global drug compliance and submissions. This is a unique opportunity to contribute to international market expansions, including the EU, UK, New Zealand, CIS, GCC, ASEAN, and LATAM regions, while advancing your career in regulatory affairs for finished formulations and oral solid dosage (OSD) products.

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Company Overview

Medreich Limited is a global pharmaceutical leader with a strong footprint in finished dosage forms, regulatory compliance, and international drug approvals. Operating with a focus on quality, innovation, and patient-centric healthcare solutions, Medreich ensures timely regulatory submissions across multiple regions. Our Corporate Office in Bengaluru serves as the hub for coordinating international regulatory affairs, lifecycle management, and strategic compliance initiatives.

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Job Role & Responsibilities

As a Regulatory Associate / Specialist, your key responsibilities will include:

• Compilation and Submission of Regulatory Documents:

  • Prepare CTD (Common Technical Document) dossiers for new applications, post-approval changes, and lifecycle management.

  • Interpret regulatory guidelines and prepare responses to quality or administrative deficiencies.

• Global Market Coordination:

  • Handle submissions to EU, UK, New Zealand, CIS, GCC, ASEAN, and LATAM markets.

  • Liaise with cross-functional teams including QA, R&D, and manufacturing to gather accurate documentation.

• Regulatory Strategy Development:

  • Support Marketing Authorization Applications (MAAs), post-approval variations, and compliance updates.

  • Ensure documentation aligns with regulatory timelines and internal standards.

• Documentation Review & Quality Assurance:

  • Conduct thorough review of all regulatory submission documents.

  • Maintain accurate records and ensure adherence to current regulatory guidelines.

• Team Coordination & Training:

  • Assist in mentoring junior associates.

  • Participate in regulatory strategy meetings and continuous process improvements.

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Eligibility / Qualifications

• Educational Background: B. Pharm, M. Pharm, or equivalent in life sciences/pharmaceutical sciences.

• Experience: 2-8 years in regulatory affairs for finished formulations / oral solid dosage products.

• Skills & Competencies:

  • Strong knowledge of global regulatory frameworks (EU, UK, LATAM, GCC, ASEAN, New Zealand, CIS).

  • Experience in CTD dossier compilation, regulatory submissions, post-approval changes, and lifecycle management.

  • Excellent communication, documentation, and project coordination skills.

  • Ability to work collaboratively with cross-functional teams.

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Location & Work Environment

• Work Location: Corporate Office, Bengaluru, India

• Office Culture: Fast-paced, professional, and internationally focused regulatory environment.

• Growth Opportunity: Work on multi-market submissions, gain expertise in global regulatory compliance, and advance your career in pharmaceutical regulatory affairs.

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Application Process

Interested candidates can submit their updated CV/resume to:

• aravinda.p@medreich.com

• swathi.ds@medreich.com

Subject Line Recommendation: “Application – Regulatory Associate / Specialist – Medreich Limited”

Tip: Ensure your resume highlights regulatory submission experience, dossier compilation, and cross-functional project coordination for enhanced consideration.

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Why Join Medreich Limited?

• Global Exposure: Work with regulatory teams across EU, UK, LATAM, GCC, ASEAN, New Zealand, and CIS markets.

• Professional Growth: Hands-on experience in CTD submissions, lifecycle management, and post-approval regulatory activities.

• Impact on Healthcare: Contribute to bringing high-quality pharmaceutical products to global markets.

• Collaborative Environment: Engage with cross-functional teams including QA, Manufacturing, and R&D.

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FAQs

Q1. What experience is required for this role?

• Candidates should have 2-8 years of regulatory experience in pharmaceutical finished formulations or OSD products.

Q2. Which global markets will I be working with?

• EU, UK, New Zealand, CIS, GCC, ASEAN, and LATAM.

Q3. Can fresh graduates apply?

• This role is designed for experienced professionals, though strong internship or project exposure in regulatory affairs may be considered.

Q4. Is relocation required?

• The role is based at the Corporate Office in Bengaluru.

Q5. How should I submit my application?

• Email your CV to aravinda.p@medreich.com or swathi.ds@medreich.com with the subject line indicating the position.

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Summary Table

Tagged as: Pharma Jobs in Bangalore