pharmalex_job_career

We are growing, grow with us

Want to work in a dynamic company with daily new challenges and opportunities?  Then is PharmaLex your career opportunity.
 
PharmaLex is one of the leading service companies for the global pharmaceutical industry and specializes in all aspects of drugs and medical devices approval of the development to market and any action to product maintenance make it as effective as possible.
The success of our company grows with the excellent expertise and the high motivation of our employees.
 
If for you, your profession is not only a job but a mission too and you enjoy working with people, then you are welcomed to come and join us.
 
To strengthen our successful team in Mannheim, we are looking, as earliest as possible for a:

Manager Regulatory Operations (m/w)

Your Job

  • Preparation of electronic applications in particular in the eCTD format for approval according to the requirements of the relevant authorities (Europe, USA, etc.) including preparation of proposals, project planning and tracking
  • Coordination, creation, compilation and validation of electronic submissions (e.g. eCTD, NeeS) for all types of regulatory activities (e.g. MAAs, PSUR, amendments, variations, renewals) in ICH and non-ICH-areas using available software
  • Acting as Regulatory Operations Lead for global submission projects, such as MAAs, NDA etc. including definition of eCTD strategy, coordination of involved publishers from various PharmaLex sites, budget and resource monitoring as well as eCTD validation and quality control
  • Project management for Regulatory Operations projects, including communication with clients and authorities
  • Support consulting for clients concerning implementation and optimisation of electronic submissions and document management and regulatory information management systems
  • Ensure the consistency, integrity and correctness of the data in the regulatory IT systems and quality assurance (e.g. preparation of SOPs and WIs and corresponding  training)
  • Support validation and maintenance of docuBridge and other software specific to Regulatory Operations
  • Collaboration in the optimization of departmental and inter-departmental processes and acting as interface to IT department
  • Communication in the project team, with customers, local partners and representatives in the international context

We offer you

  • Diversified and challenging job
  • Cooperating partnership and leeway
  • Flexible working hours based on trust
  • Continuous development opportunities through knowledge and experience as well as training

Your Profile

  • Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology) or medical informatics
  • At least 5 year of professional experience
  • Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on Regulatory Operations aspects
  • Professional experience in the area of electronic submissions, esp. eCTD and related topics
  • Capability of supervision, prioritization and processing of parallel projects and tasks
  • Project management experience, preferably in international project teams
  • Analytical thinking; seeks out diverse ideas, opinions, and insights and applies them in workplace
  • Connects and relates well with people who think and act differently than oneself
  • Embraces scrutiny and accepts feedback as opportunity to learn and improve
  • Navigates the dynamics, alliances and competing requirements of the organization or business
  • Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities
  • Professional written and spoken communication skills as well as confident English skills
  • Secure MS Office knowledge, Adobe Acrobat and database systems