Regulatory Affairs Senior Executive / Assistant Manager – Hyderabad
Position Title: Senior Executive / Assistant Manager – Regulatory Affairs (EU Market)
Company Name: Pulse Pharmaceuticals
Salary: Competitive, commensurate with qualifications and experience
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Detailed Job Description:
Role: Senior Executive / Assistant Manager – Regulatory Affairs
Industry Type: Pharmaceutical
Department: Regulatory Affairs
Employment Type: Full-Time
Role Category: Regulatory Compliance and Quality Assurance
Education:
- UG: B. Pharmacy
- PG: M. Pharmacy / MSc. (Master of Science)
Experience: 5 to 8 years of Regulatory experience in the EU Market
Key Skills: Regulatory Affairs, DMF Compilation, Dossier Preparation, Amendments, Annual Updates, LOAS Issuing, Change Controls, CCF Tracker, EU Market Expertise, Pharmaceutical Compliance
Job Description:
As a Senior Executive / Assistant Manager in Regulatory Affairs at Pulse Pharmaceuticals, you will be responsible for the following:
Primary Responsibilities:
- Compilation of Drug Master Files (DMF) and Dossiers for different Regulatory Agencies, including USFDA, EDQM, and ROW, in CTD/eCTD format as per the specified requirements.
- Preparation of amendments, updates, and annual updates for drug master files as scheduled.
- Issuing Letters of Access (LOAS) based on customer requests and handling queries from various Regulatory Agencies.
- Evaluation of change controls in alignment with current guidelines.
- Ensuring ongoing updates for Dossiers, customer queries, and Change Control Forms (CCF) tracker.
Qualifications and Experience:
- UG: Bachelor’s Degree in Pharmacy (B. Pharmacy)
- PG: Master’s Degree in Pharmacy (M. Pharmacy) or Master of Science (MSc.)
- 5 to 8 years of Regulatory experience specifically in the EU Market
How to Apply: If you meet the qualifications and have the relevant experience in Regulatory Affairs, we invite you to share your profile with us. Please send your resume to durgabhavani@pulsepharma.net.