For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Manager in Submission Publishing who will be responsible for the submission operational management and execution of the electronic publishing of regulatory submissions for national and regional regulatory agencies and operating companies. This position may oversee a team of people to achieve results, lead cross-functional working group meetings, and mentor staff members.
If you have relevant experience and would like to participate in the process, apply for this role.
what we offer
... - annual performance-based bonus
- opportunity to work with a leader in the pharmaceutical industry
- a tangible impact on regulatory processes and the development of innovative products
- hybrid work model (office in Warsaw)
- company car
- additional leave benefits (e.g., bereavement leave)
comprehensive medical care and life insurance - employer-sponsored retirement plan
your tasks
- coordinates the preparation and maintenance of regulatory submissions and filings
- utilizes regulatory information management systems and tools to assemble, publish, validate, dispatch and archive complex submissions according to internal processes and regulatory guidelines for paper and electronic submissions with a high degree of independence
- proactively provides technical training and/or guidance to submission contributors on submission requirements, standards, and processes to facilitate efficient processing by regulatory agencies
- develops departmental work practices, process enhancements / improvements, and associated training materials
- applies appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements
- may be responsible for performance oversight, development, and accountability of direct reports
what we expect
- proficient use of Regulatory Information Systems, planning, and/or publishing tools
- expert level knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines
- fluency in English; other languages may be required depending on assignment
- project or submission management skills
- therapeutic area and product knowledge, in-depth understanding of the product development process
- effective interpersonal, teamwork, and communication skills
- ability to work or lead in a matrix environment and influence stakeholders
- knowledge and skills to build productive relationships across the organization and with external stakeholders
- demonstrated problem solving, trouble shooting, and adaptability
- skill in collaborating across an organization to influence and develop work practices, standards and procedures
- skill to coach and/or mentor colleagues in applicable guidelines, standards and publishing requirements
Employment agency entry number 47
this job offer is intended for people over 18 years of age
