В крупную фармкомпанию Novartis ищут DRA Group Head LCM.
Job Description:
- Company`s global portfolio of innovative patented medicines includes more than 50 products, many of which are among the leaders in their therapeutic areas. In Medical Affairs we are encouraged to collaborate grow, and work on new ways to increase our impact in the community.
Responsibilities include, but not limited:
- Managing a team of regulatory specialist.
- Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.
- Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies.
- Serves as a regulatory liaison on the project team throughout the product lifecycle.
- Ensures rapid and timely approval on of new drugs, biologics/biotechnology and continued approved status of marketed drugs or medical devices.
Minimum requirements:
- Experience working in a cross-functional matrix structure.
- Strong project management skills.
- Minimum 5 years in regulatory affairs (as sr specialist or regulatory management).
- English - upper-intermediate.
Offer:
- Competitive salary and annual bonus level.
- Medical insurance (for the employee and children, additional discount given for close relatives).
- Life insurance, meal allowance, mobile compensation.
- Flexible working hours.
- Internal and external educational courses and trainings.
- Additional 3 additional days of paid vacation.
- Professional and career development opportunities (locally as well as worldwide).