Senior Specialist Global Regulatory Affairs

**Job Description**:
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are looking for a** Senior Specialist Global Regulatory Affairs (M/F/d) for Pharmaceuticals** to join our** **Global regulatory affairs team in Schwabenheim. This is a fulltime permanent position. GRA Pharmaceuticals is responsible for licensing of new pharmaceutical veterinary medicinal products (VMPs) and for the regulatory maintenance of licensed pharmaceutical VMPs world-wide except US.

The **Senior Specialist GRA** supports the regulatory activities related to new product registrations and life cycle management to ensure efficient new licensing, product portfolio maintenance/improvement and regulatory compliance.

**MAJOR ACTIVITIES AND RESPONSIBILITIES**
- Manage and prepare regulatory submissions
- Respond to all incoming requests with a focus on safety and efficacy in order to gain new and maintain existing product registrations
- Provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies, assess post approval changes.
- Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.
- Update GRA data bases continuously.
- Actively participate on new product development teams and/or internal projects and initiatives.
- Continuously build and share knowledge of safety and efficacy related regulations and guidelines, authority expectations, as well as current industry standards.
- Develop and maintaining a strong technical knowledge in pharmaceutical product maintenance (safety and efficacy)

**BACKGROUND REQUIREMENTS**
- University degree in Veterinary Medicine
- Preferably experience in a safety and efficacy related regulatory position
- Preferably experienced in working with international contacts, able to be patient and open to other cultural habits
- Advanced level of professionalism, experience in reviewing scientific information, leadership skills (result-oriented, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details)
- Excellent communication skills and medical writing skills.

**OUR BENEFITS**
- Flexible working hours (37.5 hours/week) and an attractive company pension scheme
- Competitive salary package: 13 monthly salaries + holiday pay (EUR 1,200 annually) + target bonus achievement
- 30 days holiday entitlement
- Hybrid working model
- Internal further training and promotion opportunities
- International cooperation
- On-the-job training
- Contribution of own ideas to the process design
- Insights into the development of veterinary medicinal products
- Corporate benefits and free (e-) parking spaces
- Good company canteen and a company health management system

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
No Travel Required

**Flexible Work Arrangements**:
Hybrid

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R193733