Senior Specialist Regulatory Affairs (m/w/d)

Job Description

We are looking for a Senior Specialist Regulatory Affairs (m/w/d) in a temporary (2 years) position at our site in Schwabenheim .

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Manage and prepare regulatory submissions with a focus on safety and efficacy, including responses to authority questions as required in each country, to gain new and maintain existing product registrations. Ensuring timely submissions.

• Develop regulatory strategies for new project developments and existing products with a view to future licensing requirements, provide regulatory timelines identify risks and propose mitigation strategies.

• Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.

• Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones.

• Critically review all safety and efficacy data and documents to meet the desired product profile and regulatory requirements.

• Critically review key regulatory submissions and assessments and provide input to help achieve earliest regulatory approval and launch of products on schedule.

REQUIREMENTS:

• University degree in Veterinary Medicine, Medicine, Pharmacy or equivalent

• 3-5 years of regulatory and/or product development experience

• Proven ability to coordinate multiple projects and priorities and meeting critical deadlines

• Strong writing and oral communication skills

• Excellent people, communication and leadership skills

• Ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details

• Strong and effective communicator and negotiator with internal and external contacts

• Proficient in English

• High level of professionalism, experience in reviewing scientific information

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

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Adaptability, Audits Compliance, Business, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Management Process, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

Job Posting End Date:

08/30/2025

*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.

Requisition ID: R356936