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

Job Description

For our innovative research location Schwabenheim (near Mainz), we are looking for a full-time and initially limited Senior Specialist Regulatory Affairs (m/w/d) – CMC – Site Transfers (#ILC) for 4 years as soon as possible.

The focus of this position is on the processing of site transfers for multiple products in close coordination with colleagues within the global regulatory affairs team and the responsible finished product manufacturing facilities.

Main responsibilities:

• Maintenance and updating of regulatory CMC dossiers
• (Co-)development of regulatory concepts and preparation of documentation for change notifications, taking into account current regulatory quality standards
• Timely response to inquiries from countries and authorities
• Technical support of other functions in regulatory issues
• Collection and maintenance of regulatory information, taking into account the associated processes, as well as maintenance of the relevant systems and databases

Your profile:

• Master's degree in Pharmacist, Chemist, Food Chemist or Biologist
• Ideally, you have professional experience in comparable positions in the pharmaceutical industry. However, applications from university graduates are also welcome.
• Consistent, flexible, team-oriented and familiar with MS Office
• Careful and responsible way of working
• You combine organizational skills with strong communication skills in an international environment
• Very good verbal and written language (English essential, German desirable)

Our offer:

• Flexible working hours (37.5 hours/week) and an attractive company pension scheme
• Competitive salary package: 13 monthly salaries + holiday pay + target bonus
• 30 days holiday entitlement (depending on location)
• Hybrid or remote working model (depending on location)
• Internal training and promotion opportunities
• International co-operations
• Training on the job
• Contributing your own ideas to the process design
• Insights into the development of veterinary medicinal products
• Corporate benefits and free (electric) car parking
• Good company canteen and a company health management program

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Job Posting End Date:

01/17/2025

Requisition ID:R327431