Senior Specialist Regulatory Affairs CMC (m/w/d)

2024-12-27

Job Responsibilities: - Maintain and update regulatory CMC dossiers. - Co-develop regulatory concepts and prepare documentation for change notifications, ensuring compliance with current regulatory quality standards. - Respond promptly to inquiries from countries and authorities. - Provide technical support on regulatory issues to other functions. - Collect and maintain regulatory information and manage the relevant systems and databases. Job Requirements: - Master’s degree in Pharmacy, Chemistry, Food Chemistry, or Biology. - Professional experience in comparable positions within the pharmaceutical industry is ideal; however, recent graduates are also encouraged to apply. - Strong organizational skills, flexibility, and teamwork orientation. - Proficient in MS Office. - Attention to detail and a responsible work ethic. - Strong communication skills in an international environment; fluency in English is essential; German is desirable. What We Offer: - Flexible working hours (37.5 hours/week). - Attractive company pension scheme and a competitive salary package (13 monthly salaries + holiday pay + target bonus). - 30 days holiday entitlement. - Hybrid or remote working options (dependant on location). - Internal training and development opportunities. - Insight into the development of veterinary medicinal products. - Corporate benefits including free (electric) parking and a company health management program. - Supportive company culture encouraging diverse ideas and collaboration.


SalaryCompetitive salary package (13 monthly salaries + holiday pay + target bonus)
Job category
Working Hours37.5 hours/week
Work Type
FULL TIME
Do you need to be in Japan
Is sponsorship available?
Do you need to speak Japanese
Is accommodation included?
Is food included?
Minimum Commitment
Minimum Commitment in Months48

Language Requirements

Fluent English
Desirable German

Requirements

Master’s degree in Pharmacy, Chemistry, Food Chemistry, or Biology.
Professional experience in comparable positions within the pharmaceutical industry is ideal; however, recent graduates are also encouraged to apply.
Strong organizational skills, flexibility, and teamwork orientation.
Proficient in MS Office.
Attention to detail and a responsible work ethic.
Strong communication skills in an international environment; fluency in English is essential; German is desirable.
Job post languageEnglish

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