Regulatory Affairs Professional

Job Overview Analyzes the requirements and prepares product related regulatory submissions. Responsibilities Collection, preparation and assembly of documentation required for various submissions to the US FDA that include but not limited to the following: Promotional materials, ANDA supplements, Annual Reports, Field Alert Reports, Adverse Event Reporting, Information Requests, external audit responses, etc. Responsible for supporting cross‑functional activities pertaining to regulatory meetings, including the development of briefing documents and conduct of meeting rehearsals. Process product complaints, including conducting the investigation and writing the final report. Interact with the Regulatory Project Manager and other project team members to ensure the timely preparation and receipt of information required for regulatory submissions. Proactively identify potential regulatory issues and recommend solutions to Regulatory Affairs management. Support business partners submissions as applicable. Drive priorities and key issues as defined by regulatory management. Be conversant and able to influence colleagues in regulatory strategies and compliance issues. Educate internal stakeholders on implications of regulations. Develop a timeline for responding to inquiries from regulatory agencies and ensure issues are addressed in a timely manner. Identify and appropriately communicate potential risks. Required Skills BS/MS in a scientific discipline. A minimum of 5 years of regulatory affairs experience in the pharmaceutical industry; sterile injectable experience preferred. A minimum of 2 years US FDA pharmacovigilance experience. Excellent communication skills (written and verbal). Excellent planning, organizational and prioritizing skills. Meticulous attention to detail and accuracy. Ability to coordinate information from cross‑functional disciplines. Working collaboratively with internal and external stakeholders. High standard of professional ethics, integrity and trust. Able to effectively multi‑task. Flexible in responding to changing project priorities. Willing to travel up to 10%. Compensation and Benefits Base Pay Range: $107,060 - $147,213. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission‑eligible position, the commission eligibility will be in accordance with the terms of the company's plan. Commissions are based on individual performance and/or company performance. Benefits include medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long‑term and short‑term disability insurance, paid parking/public transportation, paid time off, and paid sick and safe time. Equal Employment Opportunity Statement Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, click here. Reasonable Accommodations Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. Export Control A successful candidate must be able to work with controlled technology in accordance with US export control law. The company policy is to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations. #J-18808-Ljbffr Siemens Healthineers