کارشناس امور مقررات | Regulatory Affairs Specialist
اطلاعات شغل:
متن کامل آگهی:
مسئولیتها:
- نظارت و اطمینان از انطباق با الزامات نظارتی برای محصولات دارویی.
- مستندات نظارتی را برای تأییدیهها و تمدید محصولات آماده و ارسال کنید.
- با تیمهای نظارتی داخلی و به طور مؤثر ارتباط برقرار میکند و به صورت مؤثر با سازمانهای نظارتی ارتباط برقرار میکند. فرآیندهای صدور گواهینامه.
- در مورد تغییرات در مقررات به روز بمانید و تغییرات لازم را در سازمان اعمال کنید.
- با تیم های متقابل هماهنگی کنید تا از انطباق مقررات در پروژه ها اطمینان حاصل کنید.
مدرک تحصیلی:
- مدرک لیسانس در داروسازی یا فارماکولوژی.
- تجربه نشان داده شده با زبان انگلیسی، زبان انگلیسی، الزامات مربوط به صنعت داروسازی. هم نوشتاری و هم گفتاری.
- مهارت های ارتباطی قوی و توانایی کار مشترک.
Are you passionate about ensuring regulatory compliance and navigating the complexities of regulatory frameworks?
Do you want to play a key role in gaining approvals for new drugs and devices, while safeguarding patient safety?
If so, we are looking for a dedicated Regulatory Affairs Specialist to join our team in Iran.
Read on and apply today!
Your new role
As a Regulatory Affairs Specialist, you will:
- Manage GMP inspections and liaise with Iran FDA, ensuring compliant promotional activities and preventing off‑label communication.
- Monitor regulatory changes, update stakeholders, and ensure alignment with internal SOPs and local legislation.
- Oversee and coordinate regulatory submissions for NDA and LCM, including compilation, submission, and approval processes.
- Handle labelling updates, safety variations, and deviations in healthcare‑regulated processes.
- Provide regulatory guidance to cross‑functional teams such as Quality, Marketing, Legal, Supply Chain, and Medical.
- Maintain accurate use of regulatory IT systems (Vault RIM, NovoDocs, LIFT) while ensuring compliance with legal and internal requirements.
Your new department
You will be part of the Regulatory Affairs team within the Clinical, Medical & Regulatory (CMR) department.
The CMR department plays a vital role in ensuring regulatory compliance for new products and product amendments, safeguarding our license to operate.
The Regulatory Affairs team is responsible for gaining regulatory approval for clinical trial applications, new drugs, devices, and digital health solutions, as well as expanding the availability of existing products.
Based in Tehran, Iran, you will work in a collaborative and dynamic environment where your contributions will directly impact patient safety and access to innovative treatments.
Your skills & qualifications
We are looking for a candidate with the following qualifications:
- Pharm.D degree with 5+ years of experience as a Regulatory specialist, Qualified Person (QP) or QA Manager, plus background as a pharmacist, QA specialist, or R&D specialist.
- Strong understanding of regulatory requirements, including GMP inspections, product registration, labelling, and quality processes.
- Experience with safety updates, labelling variations, regulatory submissions, and use of regulatory IT systems (e.g., TTAC, IMED).
- Excellent communication, negotiation, and time‑management skills to support cross‑functional collaboration under tight deadlines. Proactive, adaptable, and improvement‑driven mindset to support evolving regulatory and quality operations.
- Fluent in oral and written English
Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases.
To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity.
For over 100 years this unordinary mindset has seen us build a company unlike any other.
One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.
Deadline
*******. Applications are reviewed on an ongoing basis.
Novo Nordisk is currently in the process of adjusting job titles globally.
Please note that the job title listed in this advertisement may be subject to change.
More detailed information will be provided during the recruitment process.
Novo Nordisk is not your typical healthcare company.
In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health.
Our unordinary mindset is at the heart of everything we do.
We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives.
Because it takes an unordinary approach to drive real, lasting change in health.
این آگهی از وبسایت ایران تلنت پیدا شده، با زدن دکمهی تماس با کارفرما، به وبسایت ایران تلنت برین و از اونجا برای این شغل اقدام کنین.