Regulatory Affairs Specialist

Are you passionate about regulatory compliance? Do you want to play a key role in ensuring the safety and availability of new and existing products? If so, we invite you to join our team as a Regulatory Affairs Specialist.

This position will be based in Bagdad, Iraq. You will directly report to the affiliate’s Head of Medical, Regulatory and Pharmacovigilance, Novo Nordisk – Iraq.

Read more and apply today for a life-changing career!

The Position

As a Regulatory Affairs Specialist, you will be responsible of planning, preparing, and timely submitting high quality files to the Health Authorities in Iraq & Iraq-KRG achieving fast approvals and keeping Life Cycle Management. In addition, you will be responsible to play a key role in stakeholder management and ensure appropriate use of communication channels to strengthen relationships with the stakeholders.

Your Main accountabilities will be to:

• Support submission planning: Apply intelligence and develop Regulatory strategy
• Create and maintain Regulatory Submission Plan including creation/review documents
• Support preparation of Regulatory file followed by submission of Dossier
• Preparation, approval and proofreading of packaging materials
• Review and approval of promotional materials to Health Care Professionals
• Hands on experience with Veeva Vault (Submission & Registrations)

Qualifications

As a Regulatory Affairs Specialist at Novo Nordisk – Iraq, you need to have Bachelor’s degree in a scientific or related field, such as Pharmacist, Biochemistry, Biology, or Microbiology. Moreover, you need to have 2-3 years of experience in regulatory affairs or a related field within the pharmaceutical industry.

To be successful in this role, you should have:

• Familiarity with regulatory requirements and compliance standards
• Strong communication and negotiation skills
• Excellent attention to details while working on multiple tasks
• Ability to work effectively with cross-functional teams, to ensure regulatory compliance and delivering excellent performance and results
• Flexibility to adapt to changing regulatory environments and requirements, ensuring continuous compliance and successful product lifecycle management
• Good computer skills
• Fluency in Arabic and English, both verbal and written

About the department

You will be part of a dedicated Good x Practice (GXP) team in Iraq, which ensures regulatory compliance for new products and variations while maintaining our licence to operate. You will collaborate closely with the medical and pharmacovigilance teams within the department, as well as work cross-functionally with other colleagues. Together, we engage with health authorities and policymakers to shape future regulatory frameworks, ensuring patient safety and the security of our medicines.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact

Please click on "apply now" to submit your resume in English.

Deadline

Apply before 26 January 2025

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.