As the Regulatory Affairs Manager (ICO), within the Global Regulatory Affairs group (GRA), you will responsible for all regional regulatory strategic and operational tasks for a range of products. The responsibilities cover products under development and/or licensed in the Intercontinental ICO region. In consultation with Global Regulatory Leads (GRLs) 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 HA approval in the fastest and most efficient way. You will be responsible for ensuring compliance with the regional regulatory requirements pertaining to product approval and license maintenance. Interacts with GRLs and other Global Regulatory Affairs Strategy Team (GRAST) members to manage and resolve cross-functional issues. You will also be responsible for lifecycle maintenance for products currently marketed in the ICO region. Actively supports regional efforts to establish and maintain effective working relationships with respective regional Regulatory Agencies and other key external stakeholders.
In collaboration with internal and external business partners, you will build and execute regional regulatory strategies for both new and existing products. Efficiently driving regulatory approvals, whilst maintaining compliance with regulatory requirements is an essential part of the role.
Qualifications & Experience
A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
At least 5 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
Experinced in 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
Highly effective communicator with written, verbal and presentation skills
Provides recommendations and solutions to supervisor, manages projects and/or staff with minimal supervision
Fluent in English. Russian and/or Spanish is advantage
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.