Join pharmalex: Regulatory Affairs Senior Specialist Vacancy in Noida/Mumbai

pharmalex Hiring Regulatory Affairs Professionals: US DMF/ASMF – Senior Specialist

pharmalex is a leading consultancy firm specializing in regulatory affairs, quality management, and compliance for the pharmaceutical and biotech industries. With a focus on innovation and excellence, pharmalex supports clients in navigating complex regulatory landscapes and achieving their business objectives. Founded by industry experts, pharmalex has established itself as a trusted partner for companies seeking regulatory expertise and strategic guidance.

pharmalex Vacancies List

• Position Title: US DMF/ASMF – Senior Specialist
• Company Name: pharmalex
• Salary: Competitive
• Company Address: Noida/Mumbai
• Industry Type: Pharmaceutical Consulting
• Department: Regulatory Affairs
• Employment Type: Full Time
• Role Category: Senior Specialist
• Educational Background Required: Bachelor’s degree in Pharmacy or related field
• Key Skills: Regulatory compliance, US FDA/EU regulations, GMP guidelines

Job Description

As a US DMF/ASMF – Senior Specialist at pharmalex, you will play a key role in regulatory affairs activities related to US and EU markets. Responsibilities include preparing regulatory documents such as DMFs and ASMFs, writing and reviewing module sections, and addressing queries from regulatory agencies and customers. Ideal candidates will have extensive knowledge of US FDA, EMA, ICH, and GMP guidelines, along with a minimum of 4 years of relevant experience.

About the Department & Responsibilities

The Regulatory Affairs department at pharmalex is responsible for ensuring compliance with global regulatory requirements and standards. As a Senior Specialist, you will work closely with cross-functional teams to support regulatory submissions and ensure timely approvals. Responsibilities include preparing regulatory documents, evaluating changes, and addressing customer queries.

How to Apply

Interested candidates meeting the specified criteria are invited to email their resumes to swati.chhabra@pharmalex.com. Please include your name, current company, relevant experience, notice period, and reason for change in the email. Only candidates with relevant experience will be considered for the position. If your profile matches our requirements, our team will contact you for further discussions.