Key Regulatory Affairs Role
The role of Senior Regulatory Affairs Officer is pivotal in ensuring the timely preparation and compilation of registration dossiers, adhering to EU or relevant Health Authority standards and corporate requirements.
Main Responsibilities:
* Lead international regulatory submissions according to company strategy and ensure registration deadlines are met.
* Respond promptly to Health Authorities' queries and deficiencies.
* Collaborate with other departments to support the timely introduction of new products into markets.
The ideal candidate will possess a life sciences degree and at least 4-5 years of experience in a regulatory affairs environment, preferably within the pharmaceutical industry. They should have thorough knowledge of current EU and other regions registration requirements for dossier preparation and procedure management.
This position requires strong analytical skills, attention to detail, and excellent communication abilities. The successful candidate will be able to manage multiple priorities effectively, working under pressure to meet deadlines.
We are seeking an individual who can demonstrate a commitment to delivering high-quality results, collaborating with cross-functional teams, and staying up-to-date with changing regulatory landscapes.
Essential Skills and Qualifications:
* Degree in Life Sciences
* 4-5 years of experience in Regulatory Affairs
* Pharmaceutical industry experience preferred
* Strong understanding of EU and regional registration requirements
Benefits:
This role offers a unique opportunity to contribute to the success of our organization, develop your expertise, and work with a talented team.
Why Choose Us?
As a leading organization in the industry, we offer a dynamic work environment, opportunities for growth and development, and a competitive package.