Masuu Global, a leading global pharmaceutical regulatory, quality services, and software company, is hiring an experienced Regulatory Affairs Manager – Formulation (EU Markets) in Hyderabad. This opportunity is ideal for professionals with 10–15 years of experience in pharmaceutical regulatory affairs, particularly those with strong expertise in EU regulatory submissions, lifecycle management, and regulatory strategy.
If you are an experienced regulatory affairs professional looking to advance your career in EU pharmaceutical regulatory submissions and compliance, this role offers the chance to work with global clients and complex regulatory pathways including DCP, MRP, and national procedures.
This Regulatory Affairs Manager job in Hyderabad is especially suited for candidates with a background in solid oral dosage forms and injectable products regulatory submissions in EU markets.
Job Overview
- Position: Regulatory Affairs Manager – Formulation (EU Markets)
- Company: Masuu Global
- Department: Regulatory Affairs
- Industry: Pharmaceutical Regulatory Consulting
- Experience Required: 10–15 Years
- Location: Hyderabad, Telangana, India
- Employment Type: Full-Time
Key Responsibilities
The Regulatory Affairs Manager – EU Markets will lead regulatory activities for pharmaceutical products and ensure compliance with European regulatory requirements.
Primary responsibilities include:
- Managing EU regulatory submissions for pharmaceutical formulations.
- Handling post-approval variations and lifecycle management for EU-authorized products.
- Developing and implementing regulatory strategies for EU markets.
- Ensuring regulatory compliance with European Medicines Agency (EMA) and national authorities.
- Preparing, reviewing, and submitting regulatory dossiers for DCP, MRP, and national procedures.
- Providing technical documentation review and regulatory guidance for pharmaceutical formulations.
- Collaborating with internal teams and global clients on regulatory consulting projects.
- Managing timelines, documentation quality, and project deliverables in regulatory affairs projects.
Required Qualifications
Candidates applying for this Regulatory Affairs Manager pharma job in Hyderabad should meet the following requirements:
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or related field.
- 10–15 years of experience in pharmaceutical regulatory affairs.
- Strong experience in EU regulatory submissions for solid oral dosage forms and injectables.
- Hands-on expertise in:
- Decentralized Procedure (DCP)
- Mutual Recognition Procedure (MRP)
- National procedures
- Post-approval variations
- Experience in pharmaceutical regulatory consulting or CRO environments is highly preferred.
- Strong understanding of EU regulatory guidelines, dossier preparation, and lifecycle management.
Why Join Masuu Global?
Working with Masuu Global’s regulatory affairs team offers several career advantages:
- Opportunity to work on international pharmaceutical regulatory projects.
- Exposure to EU regulatory frameworks and complex submissions.
- Collaborative environment with global pharmaceutical clients.
- Professional growth in regulatory consulting and compliance strategy.
How to Apply
Interested candidates can apply for this Regulatory Affairs Manager EU Markets job by submitting their CV.
Email your CV:
📧 hiring@masuuglobal.com