Regulatory Affairs Specialist EU
Regulatory Affairs Specialist EU
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Job Description
Job Summary:
Seeking a skilled Regulatory Affairs Specialist with expertise in European pre and postapproval submissions. This role involves managing regulatory processes ensuring compliance and providing strategic guidance for EU market filings.
Key Responsibilities:
- Oversee pre and postapproval submissions for the European market ensuring compliance with regulatory standards.
- Evaluate and document postapproval changes ensuring precise classification and adherence to EU requirements.
- Prepare review and submit variations and renewals for EU products coordinating effectively with crossfunctional teams.
- Interact with global regulatory colleagues to facilitate timely approvals and updates.
- Address regulatory deficiencies promptly ensuring compliance with agency requirements.
- Communicate effectively with Regulatory Authorities and IL Customers ensuring clear and professional correspondence.
- Provide regulatory strategies and guidance to IL partners and crossfunctional teams.
- Support manufacturing sites during regulatory audits ensuring compliance with GMP/QMS standards.
- Manage Marketing Authorization (MA) transfer activities within the EU market.
- Utilize Regulatory Information Management Systems (RIMS) Veeva and publishing tools for efficient submissions and documentation.
Qualifications :
Qualifications:
- Master of Pharmacy .
Skills & Competencies:
- Strong understanding of EU regulatory requirements publishing processes and eCTD submissions. National MRP/DCP CP CESP.
- Excellent communication and interpersonal skills particularly in regulatory interactions.
- Expertise in GMP QMS and plant operations to support compliance initiatives.
- Familiarity with RIMS Veeva and publishing tools for streamlined document submission.
Additional Information :
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion age sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against based on disability.
For more details please visit our career website at Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
