Johnson & Johnson Careers
Senior Regulatory Affairs Specialist
Requisition ID: 1905732058W
Janssen Turkey is recruiting for Senior Regulatory Affairs Specialist to be located in Istanbul.
The person will report to Head of Regulatory Affairs.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $6.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
- Delivers regulatory activities for areas of responsibility for new and marketed products
- Follows up and resolve the technical requests of local health authorities
- Follows up strategies set for products in locally and globally
- Prepares SmPCs and PILs with the cooperation of the medical advisors
- Proactively understands and implements all regulatory and statutory requirements
- Ensure appropriate prioritisation and resourcing of projects to deliver aligned strategic plans
- Maintains good legislation knowledge
- Actively communicate and ensure alignment with internal and external stakeholders
- Lead artwork coordination for the portfolio under responsibility
- University degree from a reputable university (preferably Pharmacy, Chemical Engineering, Chemistry or other related life sciences)
- Minimum 5 years of Regulatory Affairs experience in the pharmaceutical industry
- In depth knowledge & experience in Regulatory Affairs
- Strong communication skills and disciplined working style
- Strong in data gathering & interpretation
- Proactive, positive and innovative mindset
- Result driven and constructive team player
- Effective planning and organization skills, attention to details and excellent follow up skills
- Ability to work cross-functionally
- Excellent verbal and written communication skills in Turkish and English
- Proficiency in Microsoft Office and all related applications
- No military obligation for male candidates
Actelion Ilac Ticaret L.S. (7353)