
Senior Regulatory Compliance Manager
17 hours ago
We are seeking an experienced professional to oversee the preparation and submission of regulatory dossiers ensuring compliance and timely approvals in a dynamic and innovative environment.
Key Responsibilities:- Preparation review and submission of new applications through DCP MRP NP for EU markets.
- Establishing direct interaction with EU regulatory authorities to facilitate seamless communication.
- Effective handling of deficiencies and timely response to regulatory agencies to ensure minimal delays.
- Providing regulatory guidance and strategies to internal stakeholders and cross-functional teams.
- Master's degree in a relevant field such as Science or Pharmacy.
- A minimum of 8-12 years of experience in regulatory affairs preferably in Europe registrations.
- In-depth knowledge of EMA guidelines and regulations.
- Proficiency in spoken and written English language skills.
- Excellent interpersonal and communication skills.
Our organization actively promotes career growth and professional development through personalized learning programs. We offer a range of benefits including relocation support, family support, maternity/paternity benefits, medical coverage for yourself and your family, and life coverage for yourself.
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Senior Regulatory Compliance Specialist
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Regulatory Compliance Specialist
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Senior Regulatory Supervisor
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Hyderabad, Telangana, India Sol-Millennium Medical Group Full timeJob Description:We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will involve...