
Experienced Regulatory Affairs Professional
Há 2 dias
Regulatory Affairs Associate Job Summary
We are seeking a highly skilled and experienced Regulatory Affairs Associate to join our team. As a key member of our regulatory affairs team, you will be responsible for performing various tasks related to the submission of medicinal products to regulatory authorities.
In this role, you will have the opportunity to work on a wide range of projects, including the preparation and submission of regulatory documents, the management of regulatory databases, and the provision of support to senior colleagues.
To be successful in this role, you will need to have excellent organizational skills, attention to detail, and the ability to prioritize tasks effectively. You will also need to have a good understanding of regulatory processes and procedures, as well as experience working with different product categories.
You will be working in a fast-paced environment, and you will need to be able to meet deadlines and deliver high-quality results under pressure.
Key Responsibilities:
- Prepare and submit regulatory documents, including CTD and non-CTD format submissions.
- Manage regulatory databases, including file transfer, storage, tracking, and archival of dossiers submitted to regulatory authorities.
- Provide support to senior colleagues, including providing guidance on regulatory processes and procedures.
Required Skills and Qualifications:
- Bachelor's Degree in a Scientific or Technical Discipline.
- 3-4 years' experience in an industry-related environment in Regulatory Affairs.
- Excellent organizational skills and attention to detail.
- Able to prioritize tasks effectively and meet deadlines.
- Good understanding of regulatory processes and procedures.
- Experience working with different product categories.
Benefits:
- This is an exciting opportunity to join a dynamic and growing company, where you will have the chance to develop your skills and knowledge in a supportive and collaborative environment.
- You will have the opportunity to work on a wide range of projects, including those that involve international collaboration.
- We offer a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.
About Us:
We are a leading provider of regulatory services, dedicated to helping our clients navigate the complex world of regulatory affairs. Our team of experts has extensive experience in the field, and we are committed to delivering high-quality results under pressure.
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