Regulatory Affairs Manager Job in Hyderabad 2026 – EU Markets | Masuu Global Pharma Jobs
Regulatory Affairs Manager Job in Hyderabad – Masuu Global Pharma Regulatory Affairs Careers
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(Regulatory Affairs Manager Job in Hyderabad) |
Introduction
The pharmaceutical industry continues to expand globally, creating a growing demand for experienced professionals in regulatory affairs. Regulatory affairs specialists play a crucial role in ensuring that pharmaceutical products meet regulatory requirements and can be legally marketed in different regions.
Masuu Global, a well-known pharmaceutical regulatory consulting and software services company, is currently hiring a Regulatory Affairs Manager – Formulation (EU Markets) for its operations in Hyderabad, Telangana. This opportunity is particularly suitable for professionals who have extensive experience in European pharmaceutical regulatory submissions and lifecycle management.
The role is designed for candidates with strong knowledge of EU regulatory procedures such as Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and national regulatory pathways. Professionals with expertise in regulatory submissions for solid oral dosage forms and injectable pharmaceutical products are especially encouraged to apply.
For regulatory affairs professionals seeking a challenging and rewarding career in pharmaceutical regulatory consulting, this position offers the chance to work on global pharmaceutical projects and complex regulatory submissions.
About Masuu Global
Masuu Global is a pharmaceutical regulatory consulting, quality services, and regulatory technology company that supports pharmaceutical organizations worldwide. The company provides regulatory strategy, dossier preparation, regulatory submissions, and compliance consulting services for pharmaceutical manufacturers and biotechnology companies.
The organization works with global pharmaceutical clients to help them navigate complex regulatory environments and obtain product approvals in regulated markets, including Europe, the United States, and other international regions.
Company Headquarters
Hyderabad, Telangana, India
Founded
2016
Industry
Pharmaceutical Regulatory Consulting and Regulatory Technology
Employees
Approximately 200+ professionals globally
Masuu Global is recognized for delivering regulatory consulting services, regulatory compliance strategies, and software solutions designed to support pharmaceutical companies in regulatory submissions and product lifecycle management.
The company collaborates with pharmaceutical manufacturers, contract research organizations, and biotechnology companies to ensure regulatory success across global markets.
Job Overview Summary
Masuu Global is recruiting a highly experienced Regulatory Affairs Manager – Formulation (EU Markets) to manage regulatory submission projects for pharmaceutical products intended for European markets.
The selected candidate will play a key role in regulatory strategy planning, dossier preparation, and submission management for pharmaceutical formulations. The role requires deep expertise in EU regulatory frameworks and strong knowledge of pharmaceutical product lifecycle management.
The Regulatory Affairs Manager will work closely with internal regulatory teams and international pharmaceutical clients to ensure successful submissions and regulatory approvals in European markets.
This role is ideal for professionals who have experience managing EU regulatory submissions for solid oral dosage forms, injectable products, and other pharmaceutical formulations.
Vacancy Details
Position
Regulatory Affairs Manager – Formulation (EU Markets)
Company
Masuu Global
Department
Regulatory Affairs
Industry
Pharmaceutical Regulatory Consulting
Experience Required
10 to 15 Years
Location
Hyderabad, Telangana, India
Employment Type
Full Time
Job Responsibilities Explanation
The Regulatory Affairs Manager will be responsible for managing and coordinating regulatory activities related to pharmaceutical product approvals in European markets.
One of the primary responsibilities of this role is overseeing the preparation and submission of regulatory dossiers for pharmaceutical formulations. The professional will ensure that all regulatory documentation complies with European regulatory guidelines and submission requirements.
The role also involves handling post-approval variations and lifecycle management activities for pharmaceutical products already authorized in the EU. This includes managing regulatory updates, amendments, and variations required during the product lifecycle.
The Regulatory Affairs Manager will also develop regulatory strategies for pharmaceutical companies seeking product approvals in EU markets. These strategies will help clients navigate regulatory pathways and successfully launch their products in European countries.
Another important aspect of the role is coordinating regulatory submissions through procedures such as Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and national procedures.
The candidate will collaborate with cross-functional teams,s including formulation development, quality assurance, and regulatory documentation teams, to ensure the accuracy and completeness of submission documents.
Maintaining regulatory compliance with the European Medicines Agency (EMA) and national regulatory authorities is also a key responsibility.
Eligibility Criteria
Candidates applying for this pharmaceutical regulatory affairs position should meet the following qualifications.
Bachelor’s or Master’s degree in Pharmacy
Pharmaceutical Sciences or related scientific discipline
Professional Experience
10 to 15 years of experience in pharmaceutical regulatory affairs.
Candidates should have strong experience in EU regulatory submissions for pharmaceutical formulation,s including:
Solid oral dosage forms
Injectable products
Hands-on expertise in the following regulatory procedures is required:
Decentralized Procedure (DCP)
Mutual Recognition Procedure (MRP)
National procedures
Post-approval variations
Experience working in pharmaceutical regulatory consulting companies or CRO environments is highly preferred.
Skills Required
Candidates applying for this regulatory affairs manager position should possess strong technical and professional skills.
A deep understanding of European pharmaceutical regulatory frameworks is essential. The candidate should be familiar with regulatory guidelines issued by the European Medicines Agency and other national regulatory bodies.
Strong expertise in regulatory dossier preparation, documentation review, and submission management is also required.
The candidate should have excellent project management skills to handle multiple regulatory projects and manage submission timelines effectively.
Knowledge of pharmaceutical product lifecycle management and regulatory strategy development is also important for this role.
Communication skills and the ability to work with international pharmaceutical clients are valuable assets in regulatory consulting environments.
Salary Estimate
Although the exact salary package may vary depending on the candidate’s experience and expertise, senior regulatory affairs professionals in India typically receive competitive compensation packages.
Estimated Salary Range
15 LPA to 30 LPA
Senior professionals working in regulatory consulting firms may also receive additional benefits such as performance bonuses, professional development opportunities, and exposure to international regulatory projects.
Interview Details
Interview details will be communicated to shortlisted candidates after their applications are reviewed.
Interview Location
Hyderabad, Telangana, India
Candidates who meet the eligibility criteria and are shortlisted will be contacted by the company’s recruitment team for further interview discussions.
Required Documents
Candidates applying for this regulatory affairs job should prepare the following documents before submitting their application.
Updated professional resume
Educational qualification certificates
Government identification proof
Experience certificates from previous organizations
Salary details or current compensation information (if applicable)
Having well-organized documentation can help speed up the recruitment and interview process.
How to Apply
Interested candidates can apply for this Regulatory Affairs Manager – EU Markets position by submitting their updated CV to the company’s recruitment team.
Application Method
Send your CV via email
Email Address
hiring@masuuglobal.com
Candidates should include relevant regulatory affairs experience, regulatory submission expertise, and professional achievements in their CV.
Frequently Asked Questions (FAQs)
What experience is required for this regulatory affairs job?
Candidates should have 10 to 15 years of experience in pharmaceutical regulatory affairs, especially in EU regulatory submissions.
What regulatory procedures should candidates be familiar with?
Applicants should have expertise in Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), national procedures, and post-approval variations.
Is this job suitable for fresh graduates?
No, this role is designed for experienced regulatory affairs professionals with extensive industry experience.
Where is the job location?
The job location is Hyderabad, Telangana, India.
Final Conclusion
The Regulatory Affairs Manager – EU Markets role at Masuu Global provides an excellent opportunity for experienced pharmaceutical regulatory professionals who want to work on international regulatory projects.
With increasing demand for regulatory expertise in global pharmaceutical markets, professionals with strong knowledge of EU regulatory submissions and regulatory strategy development are highly valued in the industry.
Working with a regulatory consulting organization like Masuu Global allows professionals to gain exposure to complex pharmaceutical submissions and collaborate with international pharmaceutical companies.
Candidates with relevant experience in regulatory affairs and EU market submissions should consider applying for this position to advance their careers in pharmaceutical regulatory consulting.
Disclaimer
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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