Regulatory Affairs Specialist III

2 weeks ago

Singapur, Singapore Thermo Fisher Scientific Full time
: Support and interact with Clients for the registration of Singapore site as manufacturer of sterile medicinal products for commercial/clinical use in the main markets (US, EU and ROW (Rest of the World)). Support Clients in defining the regulatory strategy for site registration. Able to write and review of CTD Module Drug Product for new Marketing Authorizations, variations, and renewals and for Clinical Trials Applications (CTAs). Support Clients in answering to Regulatory Authorities Deficiency Letters. Manage works with key Network sites, Clients & Regulatory Agencies to shape, develop and complete regulatory strategies.

In addition this person will:

Lead interactions with Legal department and external services for notarization, legalization, translation activities for ROW registrations. Guarantee that ThermoFisher Singapore site manufacturing processes and testing are performed in compliance with the requirements of Marketing Authorization/CTA. Assure that the content of the registration dossier/CTA is acknowledged in Singapore PSG site documentation through change controls' management. Manage product life cycle maintenance changes in source, formulation, shelf life etc to ensure no impact to supply due to regulatory reason. Issue gap analysis before a Regulatory Authority Prior Approval Inspection/clinical batches batch confirmation and identify if required any appropriate corrective actions interacting with the relevant departments. Provide regulatory support to site in order to guarantee the compliance with legislations (Directives, Regulations, Italian Laws, cGMP, ICH/EMA/FDA Guidelines)/Company's policies. Support and participate to Health Authorities inspections. Maintain constantly updated Regulatory Affairs department's databases. Support to Site Quality Head and Regulatory Affairs manager for the editing of reports requested by the EU Regulatory Affairs function. Build effective working relationships with the regulatory agency HSA and follow up closely on approvals of product registration and variations. Finally, the preparation/update of the following document will part of this position's tasks: Preparation of applications supporting maintenance and extension of the site manufacturing authorizations held at the competent Regulatory Authorities, Active Ingredients Import Requests for APIs manufactured in extra-EU countries, Controlled Substances License and of the Category 1 Drug Precursors License and relevant annual reports; Maintaining Site Master Files (PIC version) update; US FDA DMF TYPE V update;

EHS:

Understand emergency procedures and follow safe systems of work. Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times Ensure timely reporting and investigation of all accidents, near misses and breaches of rules

Minimum Requirements/Qualifications:

Education

Graduation in Chemistry and Pharmaceutical Technology, Pharmacy, Biology or Biotechnology. Equivalent required.

Experience

Strong experience of 3 -6 years in RA department for a EU and FDA approved pharmaceutical company, preferably manufacturing sterile products. Expertise in writing/review of CTD Module of Drug Product for sterile products. Expertise in EU/US and ROW Submissions and in leading of documentation.

Standard knowledge of pharmaceutical technology and of analytical techniques

Knowledge of working with HSA Singapore Health Authorities and requirement. Knowledge of Directives, Regulations, Singapore HSA, cGMP, GMP Annex 1, ICH / EMA / FDA Guidelines Strong project management skills, preparations of plan and executions with adherence to plan.

Knowledge, Skills, Abilities

Good knowledge in written and oral English Analytical attitudes

Communicative attitudes

Supportive and flexible demeanour, high engagement and self-motivation, demeanor to meet timelines. Relational demeanor, with a sprit of continuous improvement and innovation Deep emotional intelligence

Benefits

We offer driven remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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