Merz North America, Inc
Aesthetics Regulatory Operations Manager (Personal Services)
**This is a remote role based in the EST**
The Regulatory Operations Manager (Ax) will be responsible for submissions management activities (planning, publishing and archiving) of Merz products, as well as the implementation/update of Regulatory systems. This role will provide operational expertise and project leadership for ongoing and future technology projects, systems, business process changes and user training. For submissions management, the Reg Ops Manager will have overall accountability in managing the logistics, planning, preparation, quality assurance, delivery and archival of regulatory submissions and allied documentation, including correspondence (drugs and medical devices) in compliance with Regulatory agency requirements, company standards, and timelines.
Essential duties and responsibilities:
Regulatory Systems:
Publishing/Dossier Management:
General Regulatory Duties:
Other duties as assigned
Knowledge, skills and abilities (incl. languages):
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Research and Development