דרושים Regulatory Affairs Specialist-licensing Poultry ב-Msd ב-הולנד

Job Description

Regulatory Affairs Specialist - Licensing (Poultry)

At Global Regulatory Affairs (GRA), we manage the licensing and maintenance of pharmaceutical and biological animal health products worldwide, We prepare high-quality dossiers and renewal packages for new and existing products while ensuring compliance with regulatory requirements across departments.

Our teams manage all regulatory aspects of their product portfolios, focusing on vaccines, with responsibilities including new product registration, regulatory maintenance, lifecycle management, and project timeline coordination. We also engage in industry groups to influence future veterinary legislation. We seek motivated professionals committed to advancing innovative and safe biological products for animals.

Purpose of the role

In this role you will support licensing activities for new registrations and lifecycle management, ensuring efficient licensing processes and regulatory compliance. Your primary focus will be on regulatory submissions and maintenance of our poultry portfolio in markets outside the EU, acting as a critical regulatory interface with agencies, regional coordinators, manufacturing divisions, and relevant departments.

Key responsibilities

Act as the primary contact within GRA for Country Operations Regulatory Affairs (CORAs) and facilitate communication between RA product managers and CORAs.

Maintain strong relationships with internal contacts (Product Managers, Operations, Pharmacovigilance) and external stakeholders (3rd party CORAs, Dutch Ministry).

Manage the submission of dossiers and variation packages to CORAs and regulatory authorities, ensuring timely follow-up and availability of required documents and materials.

Prepare and submit high-quality responses to regulatory authorities' inquiries during licensing processes, ensuring adherence to licensing strategies.

Contribute to multi-disciplinary project teams for new product registrations and licensing strategy design, while also participating in changes in registration requirements and supporting document management initiatives.

Your profile

Bachelor’s degree or equivalent in Veterinary, (Bio) Chemistry, Biology, or Biomedical fields, or demonstrated skills and experience at this level.

1 to 3 years of experience in (veterinary) regulatory affairs, preferably within veterinary biologicals.

Proficient in English, with strong oral and written communication skills.

Detail-oriented, efficient, flexible, and able to work under pressure while maintaining a service and compliance mindset.

Knowledge of country-specific licensing requirements and general product development processes, with the ability to analyze and propose solutions to licensing issues.

Proficient with information systems and capable of training colleagues with limited support, while contributing to the improvement of internal processes.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive

Competitive salary

35,5 days of leave

Attractive collective health care insurance package with considerable reduction rates

Solid Pension Plan

Flexible working arrangements

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address:

Current Contingent Workers apply

Project Temps (Fixed Term)

Adaptability, Business, Communication, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Global Regulatory, Licensing, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Product Registrations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Requirements, Regulatory Strategy Development, Regulatory Submissions, Technical Writing

*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 Description

The Opportunity

• Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
• Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
• Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.

What will you do in this role

• Build and maintain relationships with global Finance and IT colleagues to accelerate the delivery of business solutions.
• Develop a deep understanding of the Finance business processes, systems, and data related to financial close, consolidation, and external reporting.
• Explore and assess various technology solutions applicable to requirements.
• Actively participate in the technical implementation and support of key applications to help ensure alignment between business needs and solutions.
• Demonstrate the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
• Utilize open communication to acknowledge diverse thoughts and opinions.
• Demonstrate ability to independently solve problems that arise within job responsibility and expectations.
• Share best practices, tools, and techniques across product teams.
• Partner with our vendors to optimize solutions and enhance product capabilities for added value.
• Work within agile teams and contribute to common goals.
• Thrive in a dynamic, rapidly changing, highly matrixed business environment.

What should you have

• Bachelors’ degree in Information Technology, Computer Science or any Technology stream.
• 7+ years of relevant work experience, with at least 5+ years of experience working with financial systems.
• Technical/programming knowledge in using SAP HANA Studio and HANA database.
• Strong Data Analysis skills with knowledge of SAP FI/CO transactions and data engineering skills in a modern IT environment.
• Strong interpersonal and communication skills, with the ability to quickly establish credibility and trust with a variety of stakeholders.
• Strong written and verbal communications skills including the ability to communicate with both a business and technical audience.
• Critical thinker who can effectively embrace new ideas and technologies while balancing the needs of stakeholders and users.
• Familiarity with web development (HTML, CSS, API, Javascript, etc.), and Data Modeling/Design, related AWS components
• Demonstrable experience in contributing to design, build, and support of large scale IT solutions using modern technologies.
• Experience working on Agile teams and knowledge of Scrum framework.

What we look for

Current Contingent Workers apply

Data Engineering, Data Visualization, Design Applications, Software Configurations, Software Development, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, Systems Integration, Testing

*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.