
Regulatory Affairs Lead for Pharmaceutical Products
2 days ago
We are seeking a highly skilled Regulatory Affairs Lead to oversee the compliance of our pharmaceutical products in the EU market. This role requires a strong understanding of regulatory strategies and documentation requirements, as well as excellent communication and project management skills.
Key Responsibilities- Develop and implement regulatory strategies to ensure compliance with EU regulations and guidelines.
- Prepare and submit high-quality regulatory documents, including DCP, MRP, RUP, and National applications.
- Liaise with external regulatory authorities and internal stakeholders to resolve any issues or concerns.
- Maintain accurate and up-to-date records of regulatory submissions and correspondence.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
- Bachelor's degree in Chemistry, Biology, or related field.
- Minimum 2-4 years of experience in Regulatory Affairs within the pharmaceutical industry.
- Fluent English language skills and proficiency in MS Office.
- Strong organizational and time management skills, with ability to prioritize multiple tasks.
- Excellent communication and interpersonal skills, with ability to build strong relationships with colleagues and stakeholders.
- Knowledge of EU and global regulatory guidelines and frameworks.
This role offers a competitive salary and benefits package, as well as opportunities for career development and growth. If you have a passion for regulatory affairs and a commitment to excellence, we encourage you to apply.
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