Regulatory Affairs TSO Manager KSA

ARA-P3-12 Regulatory Affairs TSO Manager Location :

Riyadh, KSA Department :

Regulatory Affairs Job type :

Permanent Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. The Team

The role will join the Regulatory Affairs team in Riyadh, accountable for the regulatory affairs in Saudi, driving optimal regulatory outcomes and ensuring governance on regulatory activities. You will support PV Operations leadership as needed and act as TSO manager in KSA on behalf of the company. Role and Responsibilities

Ensure full compliance to all local and international regulations, codes and standards and company SOP. Prioritize assignments between RA and TSO aspects of role and co-ordinate multiple projects and activities accordance with company objectives. Be responsible for regulatory submissions and responses to deficiency letters, and timely tracking status of the progress, including new product registration, line extensions, variations, renewal and manufacturing site certificate application and maintenance. Ensure filing strategy is aligned with global strategy. Gather and share regulatory or safety intelligence such as current developments in the medical and scientific communities which may impact products and business with stakeholders. Ensure maintenance of appropriate systems for Regulatory activities and documentation. Ensure regulatory budget is prepared and maintained and aligned with global budget requirements. Establish and implement plans to maintain a trusted relationship with local authorities through regular meeting and discussions where appropriate. Ensure validity of Scientific Office licenses based on Local HA regulations. Respond to authorities’ inquiries related to Scientific Office. What you’ll bring

Bachelor’s degree or equivalent or higher, in Pharmacy Saudi National with a Pharmacist license from the Saudi Council of Health Specialities At least 5 years’ experience in regulatory affairs dealing with a wide variety of registration projects and issues. Experience in dealing with Pharmacovigilance matters. Thorough understanding and demonstrated ability to apply regulatory guidelines / regulations to successful dossier preparation, submission and maintenance. Ability to develop strategies and solutions within the regulatory and safety context within the scope of global requirements and available resources. Strong initiation and organization skills Outstanding written and oral communication and negotiation skills. Knowledge, experience and track record of delivering successful outcomes for regulatory, safety and TSO activities Good technical skills in the local HA online submission system or equivalent systems What we offer in return

Opportunities for learning & development through our varied programme Collaborative, inclusive work environment Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect. About Mundipharma

Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit Join our talent pool

If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles. Additional Job Description

Primary Location :

SA Riyadh Job Posting Date :

Job Type :

Permanent

#J-18808-Ljbffr