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Regulatory Affairs Manager, Cmc
vor 1 Monat
**Vacancy Name**
- Regulatory Affairs Manager, CMC
**Location of Work**
- Linz, Austria
**Employment Type**
- Full Time Employee
- At Corza Medical, our mission is to support surgical providers with remarkable service, trusted performance, and outstanding value by creating an unmatched experience that stems from listening to the surgical experts themselves.
- Our product family is the result of years of experience championing surgeons and listening to their expertise. We deliver unmatched value across our line of products and offer a seamless, personalized experience designed around surgeons’ needs. We’re a team of experienced professionals who understand the difference that excellent customer service can make.
- We are seeking a Regulatory Affairs Manager, CMC to oversee the Regulatory Affairs CMC activities for our Linz, Austria facility.**What we value**
- Integrity. _We do what is right._
- Accountability. _We do what we say._
- Customer First. _We deliver extraordinary experiences._
- One Global Team. _We before me, always._
- Inspired. _We love what we do._
**What you will do**
- Review key documents before submission (e.g. MA Transfers, MAAs, variations, supplements etc.), ensuring their regulatory compliance.
- Evaluate change proposals for regulatory impact and filing requirements.
- Interfaces with other functions/departments to assess compliance of proposed claims and labelling submissions.
- Strategic input, guidance on global regulatory requirements and potential risk anticipation.
- Provides advice on regulatory issues; and collaborates with management and cross functional colleagues (i.e., Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments).
- Provide experience interpretation and oversight of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
- Support Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and is a point of contact for Regulatory CMC on audits & inspections.
- Ensures global compliance and stays up to date on current global regulatory requirements, legislation, best practices, sharing knowledge cross functionally with key stakeholders to ensure regulatory success.
**What you will need**
- Strong scientific qualifications.
- Relevant experience in CMC Regulatory Affairs in pharma and/or medical devices.
- Experience across EMEA and possibly the USA.
- Experience providing strategic regulatory advice for the global development of products.
- SCMC and scientific advice experience.
- Understanding of GMPs, GLPs, GCPs and ICH /EMA guidelines; solid understanding of where to seek and how to interpret regulatory information.
- Ability to manage complex issues and coordinate multiple projects simultaneously.
- eCTD and electronic managements system experience.
- Strong written, verbal, listening, and communication skills.
- The ability to collaborate effectively with and lead cross-functional teams.
- Experience with trending and analysis reporting.
- Project leadership skills.
- Process improvement and management skills.
- Able to influence across the organisation.
**What you will like**
We foster a work environment where all team members are empowered and encouraged to share their opinions and ideas. We encourage robust, fact-based debate. Our highly collaborative work environment results in the best decisions for Corza Medical and a shared mission to execute our plan together, on time and on budget.**Join our team**
At Corza Medical, we are motivated by enabling our customers’ success. That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and service that will ensure the continued success of our company and surgical professionals well into the future.
