Manager Regulatory Affairs API

Job title:

Manager Regulatory Affairs API

Company:

Novartis

Job description

Job Description Summary En Sandoz, la calidad es un pilar clave para cumplir con nuestro propósito de facilitar el acceso a medicamentos de calidad para los pacientes.Como Regulatory Affairs Technician en nuestra planta de Palafolls tendrás como tarea principal la preparación de la documentación de registro (sea de nueva creación o bien el mantenimiento de los dossiers ya existentes) para el envío a las Autoridades Sanitarias y clientes y siempre asegurando que está en cumplimiento con las normativas aplicables de cada país.Job DescriptionAt Sandoz, quality is a key factor embedded in our purpose of pioneering access for patients.
As Manager Regulatory Affairs API in our Palafolls site, you’ll provide timely preparation of high-quality CMC regulatory documentation for active ingredients / intermediates under own responsibility; Formulate and lead global regulatory strategy for drug substances, under minor supervision.Your responsibilities will include:Under supervision, formulate and lead global regulatory strategy with a focus on maximizing the business benefit balanced with regulatory compliance for drug substances under own responsibility.Responsibility for innovative solutions and independent deduction and management of more complex activities for gaining and maintaining the activities according to the legislation, guidelines, good practice, and business goals. * Professional and timely planning, authoring, reviewing, coordination and/or submission of regulatory CMC documents in cooperation with relevant stockholders

• a. Compilation of drug master files and/or dossier parts and/or submission package applying agreed regulatory strategies and current regulatory trends during development, registration, and product lifecycle. Ensuring technical congruency and regulatory compliance, meeting agreed upon timelines.
• b. Submission of dossiers to the respective Health Authorities in line with applicable guidelines and align strategies.
• c. Processing of CMC documentation related customer inquiries in cooperation with adequate stakeholders during development, registration, and product lifecycle
• d. Prepare CMC responses to health authority questions during development, registration, and product lifecycle
• e. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may affect submission quality or timelines, as early as possible.
• f. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• g. Review regulatory CMC documents if sufficient level of information enabling Sandoz as MA holder to take full responsibility for the quality of the medical products and quality control of the active substances including control of mutagenic impurities as per ICH M7 guidelines. Review if sufficient information on the manufacturing and control is given and starting material designation is performed in line with requirement of the ICH Q11 guidelines and ICH Q11 Q&A documents. Compile technical assessment in line with Sandoz procedure including identify gaps and follow up with relevant tack holders.
• Generation and/or review internal regulatory guidance documents and SOPs within assigned projects
• Establish and maintain sound working relationships with colleges, partners, and customers. Provide regulatory guidance to cross-functional teams, and determine regulator impact for changes in chemistry, manufacturing, and control procedures. Support or/and lead global regulatory projects/initiatives.
• Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends. Responsibility for transfer of knowledge and experiences to the organization.
• Supervise and develop regulatory manager and associate manager registration for assigned projects
• Establish yourself and/or be a topic lead under minor supervisor for agreed subject this involves guide related discussions, provide insights. Dive deep into the topic to understand all its facts, keep abreast of the latest developments and trends.
• Work according to internal and external guidance’s, SOPs, and respective timelines.

GP6What you’ll bring to the role:PhD/Master/BSC (natural science: chemistry, pharmacy, biology, or related subjects)Minimum of 2 years work-related experience or relevant experience in pharmaceutical industry GxP areas.Desirable: 4-8 years work-related experienceBroad knowledge on Module 3Broad knowledge of regulatory guidelinesGood knowledge of relevant software toolsGood skills in presentation and scientific/technical writingGood documentation skills and able to understand and exactly follow written proceduresSound knowledge on cGMPDesirable: Knowledge on sterile API registration#SandozSkills Desired Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance

Expected salary

Location

Palafolls, Barcelona

Job date

Sat, 21 Sep 2024 07:48:31 GMT

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