Regulatory Affairs Manager Job at Masuu Global for EU markets in Hyderabad. Pharma professionals with 10–15 years experience can apply.
Company Overview
Masuu Global is a specialized pharmaceutical regulatory consulting and technology company that provides regulatory, quality, and compliance solutions to pharmaceutical organizations worldwide. The company supports global pharmaceutical clients with regulatory strategy, dossier preparation, lifecycle management, and regulatory compliance across multiple international markets.
With expertise in complex regulatory frameworks, Masuu Global works closely with pharmaceutical manufacturers, biotechnology firms, and healthcare companies to ensure successful product registrations and regulatory approvals. The company is known for offering professional consulting services that help organizations navigate evolving regulatory requirements in major global markets.
Masuu Global is currently inviting applications for the position of Regulatory Affairs Manager – Formulation (EU Markets) at its Hyderabad office. This role is suitable for highly experienced regulatory professionals who possess deep expertise in European pharmaceutical regulatory submissions and lifecycle management. Regulatory Affairs Manager Job at Masuu Global
Job Overview
| Job Title | Regulatory Affairs Manager – Formulation (EU Markets) |
|---|---|
| Company | Masuu Global |
| Department | Regulatory Affairs |
| Job Location | Hyderabad, Telangana |
| Employment Type | Full-Time |
| Experience Required | 10 – 15 Years |
| Qualification | Bachelor’s or Master’s degree in Pharmacy or Pharmaceutical Sciences |
| Industry | Pharmaceutical Regulatory Consulting |
| Application Mode | Email Application |
Job Location & Employment Type
The selected candidate will work from Masuu Global’s Hyderabad office in Telangana. This is a full-time professional position focused on pharmaceutical regulatory consulting and submission management for European markets.
Professionals joining this role will collaborate with internal teams and global pharmaceutical clients while managing complex regulatory projects related to pharmaceutical formulations. Regulatory Affairs Manager Job at Masuu Global
Open Position / Department Details
Regulatory Affairs Manager – Formulation (EU Markets)
The Regulatory Affairs Manager will be responsible for managing regulatory activities associated with pharmaceutical formulation products targeting European markets. This role requires extensive knowledge of EU regulatory pathways, dossier preparation, lifecycle management, and regulatory compliance.
The selected candidate will lead regulatory projects involving submission preparation, variation management, and regulatory strategy development for pharmaceutical products intended for EU approval.
Candidates with experience handling solid oral dosage forms and injectable products regulatory submissions will be particularly suitable for this position. Regulatory Affairs Manager Job at Masuu Global
Key Roles & Responsibilities
The Regulatory Affairs Manager will oversee multiple regulatory activities related to pharmaceutical formulation products in European markets. Regulatory Affairs Manager Job at Masuu Global
Key responsibilities include:
- Managing EU regulatory submissions for pharmaceutical formulations
- Preparing, reviewing, and submitting regulatory dossiers for European regulatory procedures
- Handling post-approval variations and lifecycle management activities for approved products
- Developing and implementing regulatory strategies aligned with European regulatory requirements
- Ensuring compliance with European Medicines Agency (EMA) regulations and national regulatory authorities
- Managing submissions under regulatory pathways such as Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and national procedures
- Conducting technical review of regulatory documentation and submission packages
- Providing regulatory guidance related to pharmaceutical formulation products
- Coordinating with cross-functional teams to ensure regulatory timelines are met
- Managing regulatory documentation quality and project deliverables
- Collaborating with international pharmaceutical clients on regulatory consulting assignments
Eligibility Criteria
Candidates interested in applying for this position must meet the following eligibility requirements.
Education
Applicants should possess one of the following academic qualifications:
- Bachelor’s degree in Pharmacy
- Master’s degree in Pharmacy
- Degree in Pharmaceutical Sciences or a related discipline
Experience
- Minimum 10 to 15 years of experience in pharmaceutical regulatory affairs
- Demonstrated experience handling regulatory submissions for European pharmaceutical markets
- Strong background in regulatory activities related to pharmaceutical formulations
Skills Required
Candidates should possess the following professional skills and expertise:
- Extensive experience with EU regulatory submissions and lifecycle management
- Hands-on knowledge of Decentralized Procedure (DCP)
- Experience with Mutual Recognition Procedure (MRP)
- Knowledge of national regulatory procedures in EU markets
- Expertise in post-approval variation management
- Strong understanding of EU regulatory guidelines and compliance requirements
- Experience in dossier preparation and regulatory documentation review
- Ability to develop and implement regulatory strategies
- Strong communication and project management skills
Experience in pharmaceutical regulatory consulting firms or Contract Research Organizations (CROs) will be considered an advantage. Regulatory Affairs Manager Job at Masuu Global
Salary & Benefits
Salary and compensation for this role will be as per company norms and based on the candidate’s experience and expertise.
Additional Benefits
- Opportunity to work on international pharmaceutical regulatory projects
- Exposure to complex regulatory submissions across European markets
- Experience collaborating with global pharmaceutical clients
- Professional development in regulatory consulting and compliance strategy
- Opportunity to handle high-value regulatory submissions and lifecycle management projects
Selection Process
The selection process for this position will typically include the following stages:
- Resume screening and initial shortlisting
- HR interaction with shortlisted candidates
- Technical interview focusing on EU regulatory expertise
- Final evaluation based on professional experience and regulatory knowledge
Candidates who meet the job requirements and perform well during the interview process may receive further communication regarding the next stages of hiring.
How to Apply
Candidates who meet the eligibility criteria can apply by submitting their updated CV via email.
Email Application
Applicants should send their resumes to:
Candidates are encouraged to include relevant details related to their regulatory experience, EU submission expertise, and professional achievements in their CV. Regulatory Affairs Manager Job at Masuu Global
Important Dates
| Event | Date |
|---|---|
| Application Mode | Email Application |
Candidates are advised to apply as early as possible, as positions may be filled once suitable candidates are identified. Regulatory Affairs Manager Job at Masuu Global
Why Apply for This Pharma Job?
This opportunity with Masuu Global provides an excellent platform for experienced regulatory affairs professionals to work on international pharmaceutical regulatory projects. The role offers exposure to European regulatory frameworks and complex pharmaceutical submissions, allowing professionals to enhance their expertise in regulatory strategy and compliance.
Working in a regulatory consulting environment also allows professionals to collaborate with global pharmaceutical companies and gain valuable experience in managing multiple regulatory pathways, submission procedures, and lifecycle management activities. Regulatory Affairs Manager Job at Masuu Global
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and life sciences job opportunities for informational purposes only. We are not affiliated with Masuu Global or any organization mentioned in this post.
Applicants are strongly advised to verify job details and recruitment information directly with the company before applying or sharing personal information.Regulatory Affairs Manager Job at Masuu Global
Final Call-to-Action
Experienced regulatory affairs professionals who have strong expertise in European pharmaceutical regulatory submissions are encouraged to apply for this opportunity. If you meet the eligibility criteria and are interested in working on global regulatory projects, consider submitting your application to Masuu Global and advancing your career in pharmaceutical regulatory consulting. Regulatory Affairs Manager Job at Masuu Global
