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- Tasks: Support product registration and ensure compliance with local pharmaceutical regulations.
- Company: Join Novartis, a leader in reimagining medicine to improve lives globally.
- Benefits: Enjoy competitive rewards, flexible work options, and a supportive culture.
- Why this job: Be part of a mission-driven team making a real impact in healthcare.
- Qualifications: 1-4 years in regulatory affairs; Korea pharmacist license preferred; strong English skills.
- Other info: Connect with the Novartis Talent Network for future opportunities.
The predicted salary is between 36000 - 60000 £ per year.
Contributes and supports the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.
Key Responsibilities:
- Achieve the best product registration with commercially attractive labelling in accordance with registration plan.
- Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance.
- Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.).
- Foster and maintain good relations with internal and external stakeholders.
- Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
- Distribution of marketing samples (where applicable).
Essential Requirements:
- For Specialist level - Preferably 1-2 years of experience in the pharmaceutical industry in a relevant field such as regulatory affairs, registration, or a directly related area.
- For Senior Specialist - Preferably 3-4 years of experience in the pharmaceutical industry in a relevant field such as regulatory affairs, registration, or a directly related area.
- Korea pharmacist license is preferred.
- Good command in English (speaking and writing).
- Good interpersonal skills.
- Strong project management.
- Ability to work under pressure.
Skills Desired:
- Analytical Skill
- Clinical Trials
- Communication
- Detail-Oriented
- Life Science
- Project Planning
- Regulatory Compliance
Regulatory Affairs Specialist/Sr.Regulatory Affairs Specialist employer: Healthcare Businesswomen’s Association
Contact Detail:
Healthcare Businesswomen’s Association Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist/Sr.Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements in the pharmaceutical industry, especially those relevant to the local market. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance and detail.
✨Tip Number 2
Network with professionals already working in regulatory affairs or related fields. Attend industry events or join online forums to connect with others who can provide insights into the role and potentially refer you to opportunities at Novartis.
✨Tip Number 3
Showcase your project management skills by discussing any relevant experiences where you successfully managed timelines and stakeholder communications. This is crucial for a role that requires maintaining good relations with both internal and external stakeholders.
✨Tip Number 4
Prepare to discuss how you handle pressure and tight deadlines, as this role demands the ability to work under such conditions. Think of specific examples from your past experiences that highlight your resilience and problem-solving abilities.
We think you need these skills to ace Regulatory Affairs Specialist/Sr.Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Regulatory Affairs Specialist position. Tailor your application to highlight relevant experience in regulatory affairs or related fields.
Highlight Relevant Experience: In your CV and cover letter, emphasise any experience you have in the pharmaceutical industry, particularly in regulatory affairs, product registration, or compliance. Use specific examples to demonstrate your skills and achievements.
Showcase Your Skills: Make sure to mention key skills that are relevant to the job, such as analytical skills, project management, and communication abilities. Provide examples of how you've successfully used these skills in previous roles.
Craft a Strong Cover Letter: Write a compelling cover letter that not only outlines your qualifications but also expresses your passion for the role and the company. Mention why you want to work at Novartis and how you align with their mission to improve lives.
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Understand Regulatory Frameworks
Familiarise yourself with the local pharmaceutical regulatory environment and key regulations that impact product registration. Being able to discuss these frameworks confidently will demonstrate your knowledge and preparedness for the role.
✨Showcase Your Experience
Be ready to share specific examples from your previous roles that highlight your experience in regulatory affairs or related fields. Discuss any successful submissions or compliance projects you've managed, as this will illustrate your capability and fit for the position.
✨Emphasise Interpersonal Skills
Since the role involves fostering relationships with internal and external stakeholders, be prepared to discuss how you’ve successfully collaborated with others in past positions. Highlight your communication skills and ability to work under pressure.
✨Prepare Questions
Have thoughtful questions ready to ask at the end of the interview. This shows your genuine interest in the company and the role. Consider asking about the team dynamics, ongoing projects, or how success is measured in the position.
