Senior Regulatory Affairs Manager in Sandoz

Job DescriptionMajor accountabilities: Team and cultureCoach and train new employees or interns.Soft people management in case of internships, mentoring, temporary assignments within the team.Back-up for Country RA Head for specific tasks (as per country needs and defined by Country RA Head)Be seen as an RA expert and experienced project lead. Leading in terms of values & behaviors.ComplianceEnsures Regulatory Compliance and Governance Guarantees compliance to overall standards required for regulatory submissions and ensures adherence to Sandoz standards, and local health authority legislation and expectations.Guarantees correct implementation and adherence to the relevant (local) procedures, and record management.Supports and as SME represents RA during internal and external audits and health authority inspections at country level.Activities to support Sandoz and our customersSupports the roll-out of the RA department strategy in country and aligns with Regional and Global regulatory strategy (where relevant)Guarantees timely creation & translation of official product information, including: Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks)Guarantees timely implementation of changes of the registered text into artworks. This can be either by overseeing or by performing the process tasks below as per country specific set-up:Perform text and Design review (manual proofreading and/or with support of electronical tools) and related documentation of created artworks according to GxP requirements.Ensure that all artworks are created as per the country specific requirements and the Sandoz brand expectations and implemented within the legal or internal timeframe.Perform the internal country responsibilities in the artwork process as described in the relevant SOPs.Strives to achieve earliest acceptance of registration applications, launches and product site transfers.Provides regulatory support (general and product-specific) to the internal organization (e.g. Business Units, Portfolio & Launch, Medical)Plays an active role in the local launch team to achieve the company’s business objectives.Strives for efficient and simplified ways of working and does this by identifying and implementing process improvement initiatives. Drive process optimization for activities under responsibilities.For the activities in scope of the role ensures that all relevant Key Performance Indicators (including safety label changes, artwork, checklists, deviations, RA input in RMP implementation and DHPC communication), are achieved timely & correctly and that all GxP and RA relevant documents are archived as per specifications.Guarantee good and professional communication between internal and external stakeholders.Be the in-country SME on RA processes, tools and/or projects in scope of the role.Assessment and rollout of global policies and new or changed legislation. Write and implement (local) SOP’s for RA processes, as applicable.Perform (or support) and document root cause investigations in case of deviations from the process and the development and execution of corrective and preventive measures.Perform and interpret KPI and compliance tracking of the operational activities.Lead (local) RA projects.General Sandoz RequirementsAdhere to Sandoz values and behaviors policies.Adhere to Sandoz's anti-bribery, confidentiality, and ethical standards and policies.Adhere to relevant GxP and pharmacovigilance requirements as established in the processes and tools.Key Performance IndicatorsTimely receipt of new Marketing AuthorizationsProper maintenance of Marketing AuthorizationsQuality of relationship with local health authoritiesTimely execution of projectsStick to defined KPI’sEducationUniversity Degree, preferably Master in Bio-Medical / Life Sciences / Pharmaceutical sciences.Min 3-year relevant work experienceProfessional ExperienceExtensive experience in the pharmaceutical industry (> 3 y)Working in a highly regulated environment.Understanding and experience of risk managementUnderstanding and experience with process optimization and SOP writing.CompetenciesStakeholder managementPlanning, organizational skills and eye for detailAccountability for actions, setting own priorities and decision takingResult orientedHigh ethical standardsLanguagesFluent in Ukrainian and English Show more Show less Посадовий рівень Старший середній рівень Тип зайнятості Повний робочий день Посадові обов’язки Юридична сфера Галузі Фармацевтичне виробництво