Associate Director, Intercontinental Regulatory Representative
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
For our location in Bern (Switzerland), Marburg (Germany) or King of Prussia (USA), we are looking for a
Associate Director, Intercontinental Regulatory Representative (100%) (m/f/d)
The Intercontinental (ICO) Regulatory Representative is responsible for all regional regulatory strategic and operational tasks for a range of products in the assigned Therapeutic Areas (TA) and region. The responsibilities cover products under development and/or licensed in the ICO Region (Latin Amercia, Eastern Europe (non-EU), Middle East and Africa).
Main Responsibilities and Accountabilities:
- As a TA Lead / Team Lead, develops and executes regional strategies, contributes to global regulatory strategies/plans and submits regulatory applications for development products and change applications for registered products in order to obtain Health Authorities’ approval in the fastest and most efficient way.
- Is responsible for ensuring compliance with the regional regulatory requirements pertaining to regulatory procedures including, but not limited to, clinical trial applications, marketing applications, change management to approved licenses, license renewals, agency meetings, Periodic SafetyReports, required reporting activities related to clinical or marketing applications/approvals.
- Interacts with Global Regulatory Leads (GRLs), Global TA leads and other Global Regulatory Affairs Strategy Team (GRAST) members to manage and resolve cross-functional issues.
- Actively supports regional efforts to establish and maintain effective working relationships with respective regional Regulatory Agencies and other key external stakeholders.
- Provides guidance to Regional Regulatory Representatives (RRR) and junior team members and actively supports the TA Lead’s efforts to continuously strengthen the team’s overall expertise and cohesion. This position requires limited supervision.
Qualifications & Experience:
- University degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
- At least 8 years of regulatory experience in a regulatory authority-facing role, supported by additional pharmaceutical /industry experience.
- Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product. Understanding of the principles of GMP, GCP and GLP.
- Strategic and tactical thinking ability complemented by a “hands on” operational approach and business planning orientation.
- Ability to identify the ‘big picture’ and opportunities/major issues and link day-to-day tasks with long-term goals.
- Demonstrated ability to lead and influence as well as to deal with rapid change.
- Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (relevant) regional Regulatory Authorities.
- Demonstrated ability to work across multiple disciplines.
- Ability to operate with minimal to no supervision and to establish professional, credible relationships within CSL Behring and externally.
- Must possess excellent interpersonal skills, successfully collaborating across geographies, cultures and functional areas.
- Fluent in English. Fluency in other languages advantageous.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.