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Regulatory Expert API
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
An exciting opportunity has arisen for a Regulatory Expert for APIs based in Arklow, Ireland.
The Regulatory Expert will support regulatory submissions of active pharmaceutical ingredients (APIs) and excipients. This role will ensure that relevant changes to product registrations and listings are properly notified to the relevant authorities and maintained. In-depth knowledge about requirements for filing, registration, and notification of pharmaceutical starting materials, excipients and APIs is required. In addition, knowledge of import and export requirements related to Good Distribution Practices for APIs is also a plus.
This role will be part of a global regulatory team and you will interact closely with the quality and operational units at the site. You will collaborate with internal experts within the business areas and across the business organisation to gather data and support efforts. Participation as the Regulatory Representative in the product development process to develop and execute regulatory strategies, assessments and plans is key, and interaction with external customers will be required.
Key responsibilities include:
- Technical writing of DMF documents in the dedicated document management system
- Support regulatory requirements on import and export of APIs
- Prepare and review documents for submission to Regulatory Agencies in compliance with requirements, to ensure their timely written submissions
- Support the regulatory tracking databases for planning, scheduling, submissions, and action dates, and overall project management
- Create policies and operating procedures to strengthen regulatory compliance
- Support the issuance of Letters of Authorization (LoA)
- Support provision of responses to Customer Regulatory Queries
- Drive and Support provision of responses to Customer Regulatory issues
Who you are:
- Bachelor or Master level of education in Pharmacy or Life Sciences with a strong emphasis in Chemistry or Biology
- Relevant industry experience and/or regulatory affairs related to APIs, pharmaceutical excipients and process materials
- Knowledgeable of US FDA and EU drug regulations, specifically for submissions in CTD format. Knowledge of regulatory landscape of other important regions, e.g., in Asia.
- Expertise in QC and QA for pharmaceutical starting materials and requirements of pharmacopeias
- Experience in submissions in CTD format. Experience in e-submission tools is welcome
- Knowledge of regulations relevant to pharmaceutical starting materials, quality requirements and preferably processing of APIs and excipients in general. You should be well-versed in regulatory trends for pharmaceutical raw and starting materials.
- Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems such as Oracle or SAP. Demonstrate good communication & project management skills. Work successfully within a multidisciplinary international team.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html