Teamlead/associate Director - Schwabenheim, Deutschland - MSD

MSD

Geprüftes Unternehmen

Schwabenheim, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 to welcome a
Teamlead/Associate Director (M/F/d)
Global Regulatory Affairs Animal Health to join our team in Schwabenheim, near Mainz, on a fulltime and permanent basis.

As the
Teamlead/Associate Director (
M/F/d) you will lead the Global Regulatory Affairs Safety and Efficacy pharma project team and be responsible for developing product safety, efficacy regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance.

Your main activities and responsibilities:

Leading, motivating and developing team members in accordance with the company's management principles
Create an inspiring team environment with an open communication culture
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
Manage and prepare regulatory submissions with a focus on safety and efficacy, including responses to authority questions as required in each country, in order 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
Assess post approval changes, provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies
Maintain regulatory information in accordance with processes and procedures to support regulatory compliance
Disseminate relevant global regulatory guidance (e.g. FDA, EMA, EPA, CODEX, VICH guidelines) and policy to interdepartmental teams and provide specific product related guidance where relevant
Develop and maintaining a strong technical knowledge in pharmaceutical product development (safety and efficacy)
Identify and communicate potential regulatory issues to management, as needed

Your Profile:

University degree in Veterinary Medicine
35 years' direct experience in preclinical, clinical, regulatory affairs or other critical areas within the veterinary pharmaceutical industry
Experienced in working with international contacts, able to be patient and open to other cultural habits
Proven ability to coordinate multiple projects and priorities and meeting critical deadlines
High level of professionalism and leadership skills (resultoriented, proactive, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details)
Experience in reviewing scientific information and medical writing skills
Strong and effective communicator and negotiator with internal and external stakeholders
Proficient in English

Our Benefits:

Trustbased 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
Onthejob 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 brings 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 w