MSD Director Global Regulatory Affairs & E 

Germany, Rhineland-Palatinate 

385538001

Job Description

Your main activities and responsibilities:

• Leading and motivating team members and creating an inspiring team environment with a culture of trust, openness, collaboration, focus, and execution

• Coaching and supporting capability development in key areas across the team and ensuring development plans for all direct reports

• Actively participating in new product development teams as well as other types of teams and initiatives and delivering on all assigned regulatory milestones

• Collaborating with project management, CMC, preclinical, clinical, R&D, and other relevant functions to develop robust regulatory strategies

• Directing team efforts to ensure timely milestone completion and high-quality regulatory submissions

• Developing worldwide regulatory strategies for new project developments and existing products with a view to future licensing requirements

• Working to assimilate global regulatory requirements and trends, including the use of state-of-the-art intelligence platforms

• Supporting the development and maintenance of standard processes and systems to maintain regulatory information and support regulatory compliance. This may involve participating in or leading complex projects related to these processes or systems

• Managing and reviewing 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 and ensuring timely submissions

Your Profile:

• University degree in Veterinary Medicine is preferable

• 5-10 years’ direct experience in regulatory affairs within the pharmaceutical industry

• Expert knowledge of regulatory affairs and regulations

• 3-5 years´ people manager experience

• 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 (result-oriented, 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

• Fluent in English. German proficiency is a plus

Our Benefits:

• Flex Time (37.5 hours/week)

• Attractive compensation package (13 monthly salaries plus cash and stock target bonus)

• Company pension plan

• Vacation allowance (1.200€ annually)

• 30 days annual leave

• Hybrid working model

• Employee benefits

• Company bike / bicycle leasing

Current Contingent Workers apply

No Travel Required

Not Indicated

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

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.