Regulatory Affairs Expert: Craft Global Strategies for Pharmaceutical Success
1 semana atrás
Job Overview
We are seeking a highly skilled Regulatory Affairs expert to join our team at Biom?Rieux Bv. As an Associate Principal Scientist, you will play a pivotal role in crafting global strategies for pharmaceutical success.
About the Role
In this key position, you will be responsible for facilitating and implementing regulatory CMC strategies for assigned small molecule products. Your expertise will ensure compliance with global regulations and guidance, as well as Company procedures.
You will work closely with the CMC Product Lead to deliver all regulatory milestones for assigned projects. Additionally, you will provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation.
Your Key Responsibilities
- Work with the CMC Product Lead to deliver all regulatory milestones for assigned projects
- Provide input to global product and project regulatory strategies
- Assess CMC changes and identify global regulatory requirements
- Critically evaluate supporting documentation to assess acceptability and identify potential risks
- Develop and execute global product and project regulatory strategies
- Lead the development, authoring, and review of CMC submission components and documentation
Requirements and Qualifications
To succeed in this role, you will need:
- Bachelor's degree in a science, engineering, or related field (e.g., Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry)
- At least 7 years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field
- Advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience
- Strong negotiation, interpersonal, written/oral communication, and fluency in English language
- Able to lead by influence and work effectively in matrix organizational structures
- Project Management skills and good understanding of change management projects
- Proven experience in critically reviewing detailed scientific information
What We Offer
We offer a competitive annualized salary range of $120,000 - $150,000, depending on experience. Additionally, we provide flexible work arrangements, including flex time and shift options. A valid driving license is required, but no hazardous materials handling is involved. This is a single opening with no relocation requirements and no visa sponsorship available.
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