Industry Leader: Regulatory Affairs Professional
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As a key member of our organization, you will play a vital role in ensuring the smooth operation of our regulatory affairs department. Your primary responsibilities will include managing marketing authorizations, variations, and renewals applications for medicines, medical devices, cosmetics, and food supplements.
Key tasks include:
* Coordinating with cross-functional teams to ensure timely submission of regulatory documents;
* Developing and maintaining technical dossiers for medicinal products and medical devices;
* Preparing and submitting translations of regulatory procedures to authorities;
* Conducting readability tests and developing bridging reports;
* Creating clinical and non-clinical reports;
* Managing price and reimbursement applications;
* Ensuring compliance with relevant regulations and guidelines.
In addition to these core responsibilities, you will also be expected to develop and maintain relationships with internal stakeholders, including pharmacists, quality assurance specialists, and other support staff.
We are looking for a highly organized and detail-oriented individual who is passionate about regulatory affairs and has a strong understanding of the latest industry developments. The ideal candidate will possess excellent communication skills and be able to effectively collaborate with colleagues at all levels.
Responsibilities:
1. Manage marketing authorizations, variations, and renewals applications;
2. Develop and maintain technical dossiers;
3. Prepare and submit translations of regulatory procedures;
4. Conduct readability tests and develop bridging reports;
5. Create clinical and non-clinical reports;
6. Manage price and reimbursement applications;
7. Ensure compliance.
Requirements:
* Graduate degree in Pharmaceutical Sciences or life sciences;
* At least 2 years' experience in Regulatory Affairs;
* Excellent communication and interpersonal skills;
* Proficiency in spoken and written English;
* Ability to work independently and as part of a team.
Benefits:
* Competitive salary and benefits package;
* Opportunities for professional growth and development;
* Collaborative and dynamic work environment;
* Recognition and rewards for outstanding performance.
How to Apply:
If you are a motivated and detail-oriented individual with a passion for regulatory affairs, please submit your application, including your resume and cover letter, to us via LinkedIn or email.
We thank all applicants for their interest; however, only those selected for an interview will be contacted.
Personal data collected for recruitment purposes will be used solely for that purpose, as defined in our General Data Protection Policy.