Drug Regulatory Affairs Associate Not vacantonly for sourcing

.

Job Purpose

In accordance with CPO strategy provide Regulatory Affairs knowhow

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

Highquality and timely Regulatory Affairs knowhow 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

f 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

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.

Job ID 73423BR

Position Title Drug Regulatory Affairs Associate Not vacantonly for sourcing

Division Over The Counter

Business Unit Over The Counter

Country Denmark

Work Location Copenhagen

CompanyLegal Entity Denmark Novartis Healthcare AS Copenhagen

Fu more...

JBS

via http://ift.tt/1cf7WGT

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