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Director Regulatory Affairs

Unique opportunity to set your mark on the future Regulatory Affairs function in a highly scientific biotech company

 

As Director Regulatory Affairs at Symphogen you will be responsible for the regulatory function, which includes being accountable for regulatory input to the global development strategy and for the regulatory project leadership for dedicated projects.

Further, you will be responsible for ensuring compliance with regulatory rules and regulations for clinical development in US, Europe, and Rest of World (RoW) in collaboration with local and global regulatory colleagues. You will work closely with cross functional teams and line functions in Servier France and in Denmark. Another important part of the role is to supervise and manage contractors and vendors related to regulatory outsourcing.

The position is newly established, and this is a unique opportunity to be part of setting up the structure and function of Regulatory Affairs and play a key role in providing effective support to the organization to ensure the best development programs.

Your main responsibilities include:

  • Prepare regulatory strategy for dedicated project(s) as core team member
  • Direct and drive the preparation of INDs, Annual Updates, and other submission processes
  • Provide regulatory input to submissions and ensure that appropriate regulatory strategies are executed for clinical development programs, including RA CMC input and CDx strategies
  • Provide regulatory input and risk assessment to Core Teams, Project teams and to line functions as per request
  • Review/approve regulatory and safety input for submission documents, including clinical protocols, IB, DSUR, clinical trial reports, expedited safety submissions, and annual reporting obligations
  • Lead/supervise regulatory planning for preparation and amendments of clinical trial application (CTAs/INDs) to the authorities world-wide
  • Contribute to ensuring best use of Regulatory Document Management Systems
  • Lead/coordinate all interactions and negotiations of regulatory requirements with any regulatory authority directly or through established agent
  • Ensure timely and compliant submission (electronic or paper) of regulatory submissions e.g., CTAs/INDs, MAAs, BLAs directly or through partners (e.g., CROs)
  • Maintain current knowledge of FDA, EMA and RoW guidelines pertaining to Regulatory Affairs and communicate to colleagues and collaborators when required

Your qualifications include at least +5 years of documented professional experience from a regulatory affairs position in the pharmaceutical industry working within the R&D area of regulatory affairs.

The following qualifications are appreciated:

  • Experience interacting directly with regulatory authorities on an international scale
  • Comfortable in a variety of disciplines including CMC, Clinical and Non-clinical areas
  • Detailed knowledge of related rules and regulations, and best regulatory practices, preferably concerning biological drugs
  • Be adept at formulating and driving strategy, tactically oriented in preparing and writing submissions, and be proficient at playing a hands-on role
  • A successful track record in moving therapeutic products through various stages of development and approval
  • Ability to collaborate effectively with multiple functions, including research, development, clinical, and quality
  • Dossier preparation experience in the US and the EU is a plus

You have a Master’s Degree in Pharmaceuticals, Chemical Engineering or similar and are fluent in English at a professional level, both written and spoken.

You are a person with strong interpersonal skills as you will serve as a major contributor and trusted member of the project development teams. Further, you are comfortable in a dynamic environment in which priorities and drivers can change rapidly. Also, you have the ability to think and manage strategically while at the same time being operational. You have a high energy level, passion, and sense of urgency for developing important new medicines for devastating diseases.

Symphogen offers a challenging and versatile job in an innovative, flexible, focused and committed biotech environment. Moreover, they offer strong cross-functional teamwork, room for individual performance and development, and passionate, inspiring, and fun colleagues.

You will be the main driver in building the Regulatory Affairs function and as Symphogen is growing, you will be responsible for setting the future direction for the Regulatory function. Also you will be working closely with your colleagues in Servier.

Travelling: 1-2 weeks a year.

Domicile: Symphogen’s office in Ballerup.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Jeanne Dederding, Unique Human Capital on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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