Sr. Spclst, Regulatory Affairs-CMC (m/f/d)

Merck; Unterschleißheim; Hybrid; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company is seeking a Senior Specialist in Regulatory Affairs to manage site transfers for multiple products. This role involves maintaining regulatory dossiers, developing regulatory concepts, and supporting other functions effectively. Candidates should possess a Master's degree and strong communication skills, particularly in English. Offering hybrid work model, competitive salary, and attractive benefits, this opportunity is ideal for those passionate about enhancing regulatory compliance in a dynamic environment.

Leistungen

Flexible working hours

Attractive company pension scheme

30 days holiday entitlement

Internal training and promotion opportunities

Corporate benefits and free parking

Qualifikationen

• Master's degree in Pharmacist, Chemist, or related field is mandatory.
• Professional experience in the pharmaceutical industry is preferred.
• Strong communication skills in English; German is desirable.

Aufgaben

• Maintain and update regulatory CMC dossiers.
• Develop regulatory concepts and prepare documentation for change notifications.
• Respond to inquiries from countries and authorities in a timely manner.
• Provide technical support on regulatory issues.

Kenntnisse

Accountability

Adaptability

Biochemistry

Business Strategies

Chemical Biology

Database Maintenance

Detail-Oriented

Employee Training Programs

Intercultural Communication Training

Mentorship

Pharmaceutical Management

Pharmacodynamics

Pharmacokinetics

Professional Etiquette

Project Management

Quality Assurance (QA) Standards

Quality Standards

Regulatory Affairs Management

Regulatory CMC

Regulatory Communications

Regulatory Compliance

Regulatory Compliance Audits

Regulatory Experience

Ausbildung

Master's degree in Pharmacist, Chemist, Food Chemist or Biologist

Jobbeschreibung

Job Description

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

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

Required Skills

• Accountability
• Adaptability
• Biochemistry
• Business Strategies
• Chemical Biology
• Database Maintenance
• Detail‑Oriented
• Employee Training Programs
• Intercultural Communication Training
• Mentorship
• Pharmaceutical Management
• Pharmacodynamics
• Pharmacokinetics
• Professional Etiquette
• Project ManagementQuality Assurance (QA) Standards
• Quality Standards
• Regulations
• Regulatory Affairs Management
• Regulatory CMC
• Regulatory Communications
• Regulatory Compliance
• Regulatory Compliance Audits
• Regulatory Experience

Preferred Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Project Temps (Fixed Term)

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

25%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

12/27/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.