Position Title Drug Regulatory Affairs Associate - Not vacant/only for sourcing

 Job ID    73423BR

Division    Over The Counter
Business Unit    Over The Counter
Country    Denmark
Work Location    Copenhagen
Company/Legal Entity    Denmark Novartis Healthcare A/S, Copenhagen
Functional Area    Development & Medical
Job Type    Full Time
Employment Type    Regular

Job Description    Job Purpose:
In accordance with CPO strategy, provide Regulatory Affairs know-how
and support to
• clinical trial applications
• planned filing and approvals of new products in Denmark and Iceland
for fast access to the market in order to optimize growth of market
share, sales and product results, both short and long term in defined
therapeutic areas. The long term perspective includes regulatory
maintenance of the products on the Danish and Icelandic market.

Major Accountabilities:
- High-quality and timely Regulatory Affairs know-how input into clinical
trial applications, planned filing and approvals of new products,
variations, reimbursement applications and adequate maintenance of
established products in accordance with global and local regulatory
plans.
- Update Dragon accordingly.
- Build and keep a highly professional relationship with the departments
at the Danish National Board of Health dealing with medicinal products
and thereby ensure a good atmosphere in the working relationship.
- Support central regulatory- local and Scandinavian market access -
local medical- and local marketing functions in accordance with CPO
strategy.
- Interact with ICRO, logistics, QA, marketing (project and product
teams) and sales to best support local and global interest for
development projects and products on the market and ensure adequate
communication with relevant stakeholders.
- Stay updated with current regulatory legislation and guidelines in the
local market and EU. Share information with colleagues and HQ if
appropriate.

Key Performance Indicators:
- Timely submission of variations, clinical trial applications,
reimbursement applications, PSURs, ASRs and high quality translations
of SmPC’s
- Maintenance of Dragon within the timeframe required in the SOP’s
- Timely delivery of clinical trial approvals and information concerning
- Marketing Authorisations and changes in the MAs
- Quality in relationship with authorities and customers
Minimum requirements    Education:
Master of Science in Pharmacy or other relevant biomedical background

Language:
Excellent medical English and excellent medical Danish

Experience:
Preferably some years of working experience in the
pharmaceutical industry as Regulatory Affairs Associate. Desirably
experience from Health Authority. Experience in medical and
pharmaceutical writing + IT literacy (MS Office package).

Apply