Senior Regulatory Affairs Manager
vor 1 Tag
**Role Overview**
We are seeking an experienced Senior Regulatory Affairs Manager to join our team at CARBOGEN AMCIS.
This is a challenging opportunity for a highly skilled professional to lead our regulatory affairs function and drive the success of our organization in terms of compliance, quality, and customer satisfaction.
Key Responsibilities:
- To develop and implement global regulatory strategies that ensure CARBOGEN AMCIS products meet or exceed all applicable regulations.
- To provide strategic guidance on regulatory requirements and to advise management on potential impact on business operations.
- To maintain relationships with regulatory authorities worldwide and keep abreast of new developments and changes in regulatory environments.
- To prepare, review, and submit high-quality regulatory documents and applications, including DMFs, CMC documents for INDs, IMPDs, NDAs, MAAs, etc.
- To coordinate and manage the e-CTD submission process.
- To facilitate the development and implementation of processes and procedures that ensure compliance with relevant laws and regulations.
- To take ownership of process improvement initiatives within the RAC department.
Requirements:
- A Ph.D. Chemist or Pharmacist or equivalent scientist experience.
- Extensive knowledge in RAC (drug substances and/or drug product) and CMC development.
- Strong understanding of GMP principles and practices.
- Familiarity with e-CTD systems.
- Minimum 5 years of experience in a RA department (Drug Substances or Drug Products).
- Minimum 5 years of work or management experience in a RA/GMP environment.
- Minimum 5 years of experience in dealing with authorities and customers.
- Minimum 5 years of experience in leadership or consultancy.
- Excellent intercultural skills.
- Good to excellent communication style.
- Good English language skills, orally and in writing.
- Flexible working attitude (ready to work overtime).
- Team-oriented leadership skills with strong decision-making capabilities.
What We Offer:
- A dynamic work environment with high-quality infrastructure.
- Interesting opportunities to develop your professional skills.
- Flexible working hours for a 40-hour week.
- At least 5 weeks of vacation.
- Participation in childcare costs.
- Travel insurance for private travels.
- Private insurance in the event of an accident.
- The 13th monthly salary is paid out without any social benefits deductions, and there is a profit-sharing scheme in a successful business year.
Estimated Salary Range: €120,000 - €150,000 per year.
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