327 days ago on sire-search.com

Sr. Director Regulatory Affairs - Pharma

SIRE Life Sciences

  • Work region
  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Sr. Director Regulatory Affairs - Pharma

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Zug Switzerland.

Our client is a large Pharma organization in Central Switzerland

ROLE DESCRIPTION

Responsible for providing regulatory leadership to complex and/or high priority project(s) or a complex group of programs. Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.

RESPONSIBILITIES

- Timely submission of high quality dossiers that maximize probability of approvals with best label reflecting the target product profile based on the data.
- Identification of significant issues and options for addressing them in the Seed document.
- Regulatory strategy presented to boards and endorsed by DRA management.
- Successful HA interactions that optimally achieve Development objectives based on the data available.
- Fulfil regulatory responsibilities to the GPT to achieve business objectives.
- Effectively negotiate labelling changes and post-approval commitments.
- Effectively maintain/defend marketed products and ensure fulfilment of post-approval commitments.

REQUIREMENTS

Science based BS or MS with requisite experience and demonstrated capability.
Advanced degree (MD, Ph D, PharmD)
Fluency in English (oral and written). Additional language is an asset.
Minimum 8-10 years of regulatory and drug/biologic development spanning activities in Phases I-IV in most or all of the following areas:
Major involvement in CTD/MAA/NDA submissions and approvals.
Regulatory operational expertise
Minimum 5 or more years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
Minimum 5 or more years people management experience required;

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.