Regulatory Affairs API Manager
hace 4 semanas
At Sandoz, quality is a key factor embedded in our purpose of pioneering access for patients.
This role provides timely preparation of high-quality CMC regulatory documentation for active ingredients/intermediates under responsibility, formulating and leading global regulatory strategy for drug substances under minor supervision.
Key Responsibilities:1. Under supervision, formulate and lead global regulatory strategy with a focus on maximizing business benefit balanced with regulatory compliance for drug substances under responsibility.
2. Responsibility for innovative solutions and independent deduction and management of more complex activities for gaining and maintaining activities according to legislation, guidelines, good practice, and business goals.
3. Professional and timely planning, authoring, reviewing, coordination and/or submission of regulatory CMC documents in cooperation with relevant stakeholders.
4. 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.
5. Submission of dossiers to the respective Health Authorities in line with applicable guidelines and align strategies.
6. Processing of CMC documentation related customer inquiries in cooperation with adequate stakeholders during development, registration, and product lifecycle.
7. Prepare CMC responses to health authority questions during development, registration, and product lifecycle.
8. 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.
9. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
10. Review regulatory CMC documents to ensure Sandoz as MA holder can 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.
11. Generate and/or review internal regulatory guidance documents and SOPs within assigned projects.
12. Establish and maintain sound working relationships with colleagues, partners, and customers. Provide regulatory guidance to cross-functional teams and determine regulatory impact for changes in chemistry, manufacturing, and control procedures. Support or/and lead global regulatory projects/initiatives.
13. 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.
14. Supervise and develop regulatory manager and associate manager registration for assigned projects.
15. Establish yourself and/or be a topic lead under minor supervision for agreed subjects, guiding related discussions, providing insights, and keeping abreast of the latest developments and trends.
16. Work according to internal and external guidance, SOPs, and respective timelines.
Requirements:1. PhD/Master/BSc (natural science: chemistry, pharmacy, biology, or related subjects).
2. Minimum of 2 years work-related experience or relevant experience in the pharmaceutical industry GxP areas.
3. Desirable: 4-8 years work-related experience.
4. Broad knowledge on Module 3.
5. Broad knowledge of regulatory guidelines.
6. Good knowledge of relevant software tools.
7. Good skills in presentation and scientific/technical writing.
8. Good documentation skills and able to understand and exactly follow written procedures.
9. Sound knowledge on cGMP.
10. Desirable: Knowledge on sterile API registration.
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