Regulatory Affairs Manager
|Job Title:||Regulatory Affairs Manager|
|Location:||San Diego, California|
|Contact Name:||Pavlina Bullaj|
|Job Published:||January 29, 2018 19:45|
Regulatory Affairs Manager
SciPro Global have been engaged by one of our key clients in Southern California, a biotech company, in finding Regulatory Affairs manager to join their growing Regulatory Affairs team. Working as part of the team you will take part in the developing of regulatory strategies, planning, managing & executing regulatory activities.
As the Regulatory Affairs Manager you will need to demonstrate strong knowledge of pharma/biotech FDA submissions skills and a drive for results that are needed to achieve company objectives in accord with client's culture and core values.
Role & Responsibilities:
- Support the executive team to develop US regulatory strategies and work with the global regulatory team towards the development of global regulatory strategies
- Provide strategic input to the global Regulatory team for all US-based Regulatory Affairs matters, including the seeking of Scientific Advice
- Define and execute strategies for regulatory submissions for INDs/ NDAs/BLAs and required maintenance (amendments, notifications, supplements, renewals, annual updates) for drug products in the US & internationally
- eCTD submission experience would be highly preferred but not necessary
- CMC regulatory submissions experience is a strong plus
- Manage customization of IND dossiers, and organize submission and registration of drug products in a professional, compliant, and timely manner
- Support the writing and review of SOPs and assist in inspection readiness programs
- Serve as a representative of the client to the US regulatory community; serve as a liaison with the FDA to support effective professional and company relationships
- Educate project teams on regulatory pathways and requirements to ensure effective product development and registration
- Maintain an effective archiving system
- Ensure that the pharmaceutical products distributed in the US meet FDA requirements and support the local commercial organizations
- In partnership with other regulatory staff, maintain and expand current knowledge of regional regulatory requirements and precedents that may affect the clinical development and commercialization of company products
- Support contractor selection and coordination of contracted activities
- Masters or Bachelor's degree, preferably in life sciences
- Minimum of 5 years of Regulatory experience
- CMC regulatory submission experience a plus but not required
- eCTD experience highly preferred
If you are looking to join an open and collaborative team who are keen on your development to gain not only national but also international experience within the Regulatory Affairs space, then this could be for you.
If you would like to learn more about this position, please apply directly or feel free to send me your contact details/ updated resume to firstname.lastname@example.org for more information.
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