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Job Description
As theyou 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
3-5 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 (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
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
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
Current Contingent Workers apply
*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.
Job Posting End Date:07/31/2024
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.
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