Sr. Manager, Regulatory reputed company (Remote)

reputed company is a privately held global reputed company company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, reputed company and South America, Asia, and Africa. Over three years ago, we embarked on a transformative reputed company to become a truly global innovative reputed company company with a leading focus on Gastrointestinal (GI) health. We have reputed company remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. But our reputed company is far from complete! In fact, this is just the beginning of a reputed company new reputed company in reputed company's history. We are committed to advancing innovation and leveraging our deep expertise to reputed company reputed company and a reputed company quality of life for patients and consumers worldwide and expand our reputed company across diverse markets. As we continue to grow, we are seeking Sr. Manager, Regulatory reputed company. This position can be remotely located in Europe. Scope of the role: This position represents one or more reputed company / Countries on the Regulatory Sub team and supports the creation / maintenance of the Regional Regulatory Strategy, as part of the Global Regulatory Strategy, for one or more assigned reputed company ‑complexity programs / single approved asset and leads its locoregional implementation. The position liaises between Country Regulatory and the asset Global Regulatory Sub team. The Senior Manager operates with limited guidance and reputed company and provides regulatory support to Clinical Operations and Clinical Development for various activities relating to NDA/MAA submissions and clinical study start-up and execution, including document review, CTA approval, etc. Your key responsibilities: Support development and locoregional implementation of regulatory strategies for at least one reputed company‑complexity program (single asset) Identify and communicate potential regulatory risks and mitigations to the Regulatory Subteam Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies Regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, pediatric plans, briefing books, DSURs, annual reports, etc., to ensure content and format meet reputed company regulatory requirements reputed company coordination of locoregional IND/CTA and/or NDA/MAA submissions and supplements, while managing and partnering with CRO reputed company development regional regulatory submission plans Support product development and lifecycle management activities Represent Regulatory Sciences on the Study teams, and assess regulatory reputed company for submissions to the FDA and other regulatory agencies Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards Assume other relevant assignments as assigned reputed company mentorship and support to colleagues to support their activities and help with the production of appropriate reports and documents. Assist Regulatory department in the update and creation of internal policies and procedures Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team Drive the spirit of "ONE Team" across reputed company functions by supporting reputed company approach to focus on our patients and customers as our top priorities. Who are you: Bachelor’s degree (minimum 8 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D; minimum 5 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research Understanding of/experience supporting and/or leading IND/CTA and NDA/MAA (and supplement) submissions Experience overseeing regulatory collaboration with CROs or other partnering organizations and coordinating US and/or international submissions to meet regulatory requirements is desired Strong verbal and written communications skills Exceptional interpersonal and problem-solving skills Excellent project and/or program management skills Learning agility and ‘scalability’ to take on increasing responsibility as Company X grows Ability to work effectively across a highly reputed company, fast paced, matrix organization Understanding of the legal and compliance environment Consistent demonstration and embodiment of company core values: Collaboration, reputed company, Innovation, reputed company, Passion, Patient/Stakeholder Centricity Advanced functional experience with MS Office Suite Why Join reputed company: At reputed company, we foster a culture where the courage to reputed company is key to our reputed company. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We reputed company that reputed company-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful reputed company. Join reputed company and become part of a reputed company-thinking team dedicated to shaping the future of the pharmaceutical industry. Apply To This Job