Regulatory Affairs - Labelling Director (m/f/x)

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Date: 01-Jul-2022

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

For our headquarters in Munich we are seeking highly qualified candidates to fill the position:

 

Regulatory Affairs – Labelling Director  (m/f/x)

Purpose of the function:          

This position serves as the Global Regulatory Affairs (GRA) Labelling Strategy expert to the Global Product Team (GPT). As an ad hoc member the incumbent provides strategic and operational leadership on new product labelling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products.
 

The Labelling Director leads the development and maintenance of the CCDS, US and EU labelling, and manages the review of country labelling deviations for assigned Daiichi Sankyo products. This includes ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and company business objectives. In addition, this role manages new projects and projects of increased complexity including those involving 3rd party collaborators. 
 

The position will have regional EU labeling expertise and may serve as a Global Labeling Lead. As part of the Global Labelling Operations & Compliance group, this position mentors assigned staff to achieve high quality and accurate labelling in support of business objectives.

                                                                                                                                            

Roles and Responsibilities:

  • Lead the development of the Company Core Datasheet (EU and US Documentation): As the project lead, manage, develop, prepare and implement regulatory for new products or products in the development phase

  • Lead cross functional teams through all labelling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed

  • Acts as point of contact for cross-functional teams on RA labelling issues

  • Collaborate with Regulatory Affairs and Labelling colleagues in other regions, including Japan, while developing the CCDS

  • Ensure Compliance with Core Data Sheets/Label Changes: Develop and communicate the strategic labelling development plan to the other project team GLLs and to cross-functional labelling review team members

  • Conduct Label Review Committee Meetings: Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and where applicable, partner companies for the development and approval of US, EU and global CCDS documents for regulatory filings and HA labelling discussions. Collaborate closely with colleagues in Japan and with country RA

  • Demonstrate expert knowledge of global labelling guidance to ensure compliance

  • Collaborate with Global Labelling Operations and Compliance leads to product high quality labelling documentation

  • Establishes Process Best Practices: Lead the development of Standard Operating Procedures (SOPs) and process improvements. Conduct team meetings with direct reports or a team of GLLs to ensure alignment of labelling content and strategy and to optimize resources

  • Builds cross-functional and cross-regional relationships

  • Mentor, develop and manage assigned staff and/or matrix team members

                                                                                             

Qualification and Requirements:

  • Degree (Bachelor, Master, State Examination, Diploma) preferably in a scientific degree, e.g. in Pharmacy, Medicine, or Life or Natural Sciences; Master, Pharm. D.  or PhD preferred

  • At least 10 years of working experience in Pharmaceutical Industry, at Clinical Research Organizations or at an EU Regulatory Authority with at least 5 years of experience in Regulatory Affairs including CCDS and EU/US Labelling experience.

  • Experience with country labelling (outside the US/EU) is a plus

  • Experience of working in global environment

  • Proven ability to plan, coordinate and lead activities simultaneously on multiple projects

  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization

  • People leadership experience

  • Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner

  • Solution and detail-oriented; well-organised and self-motivated

  • Excellent written and oral communication skills in English, second EU language preferred

 

What we offer


Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.