Regulatory Affairs and Scm

Regulatory AffairsThis is us:Ovesco Endoscopy is a research-based medical device company specializing in flexible endoscopy.We develop, produce, and sell highly innovative instruments and systems for the treatment of gastrointestinal diseases. We offer comprehensive procedures and accompany our customers all the way from training to intervention.This is you:...

Ongoing, Full-Time INR64,821 per month Chennai, IndiaAbout the Department of Foreign Affairs and TradeThe role of the Department of Foreign Affairs and Trade (DFAT) is to advance the interests of Australia and Australians internationally. This involves strengthening Australia's security, enhancing Australia's prosperity, delivering an effective and...

Req ID: 502507 Job Description Are you inspired to contribute your expertise to a global leading Ingredients organization? We are a global leader in taste, scent and nutrition, offering our customers a broader range of solutions for the food & beverage industry. We are looking for a dedicated and passionate individual to join our Global Regulatory...

Req ID: 502507Job DescriptionAre you inspired to contribute your expertise to a global leading Ingredients organization? We are a global leader in taste, scent and nutrition, offering our customers a broader range of solutions for the food & beverage industry. We are looking for a dedicated and passionate individual to join our Global Regulatory Affairs...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient...

Work Location Assignment: On PremisePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory AffairsLI-PFE

Functions as Regulatory support for assigned projects and the life-cycle changes; works with Project Leads/Product Leads, cross-funcational teams, local and regional regulatory colleagues, external partners (in-licensed products) and Global Health Authorities (if required) to independently frame and drive global regulatory strategies for post approval...

Responsibility: Functions as Support to Product Lead for Life Cycle Management (LCM),- working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections for post approval submission. Responsible for...

Responsibility: Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:Step 1 Assessment for Nitrosamine riskStep 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning:...

To handle global tenders and ancillary documents through relevant internal system/tools and stay compliance with Pfizer policyWork Location Assignment: FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory AffairsLI-PFE

Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines. Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL. Authors and/or compiles CMC contributions...

QualificationsMust-Have Bachelor's Degree Proven ability to manage complex regulatory or drug development issues Knowledge of the regulations and guidelines in the various markets Strong relationship with the local health agency and other relevant stakeholders and proactively manages issues with key external stakeholders Good skills on communication,...

Role Summary:Functions as the CMC author & strategist for the Life Cycle Management (LCM) activities of assigned products and/or projects providing regulatory assessments and developing regulatory strategies for global markets including US/EU/APAC/LATAM & AfME regions; Accountable for assigned projects and activities, completing work within assigned product...

As a Information Security Compliance Manager within the unit responsible for managing ISO standards implementation, client information security audits, internal information security audits, certifications such as SOC 2 Type 2, PCI DSS, regulatory audits, and artefact collection, review, and management,ResponsibilitiesISO Standards Implementation Responsible...

Business Director - Chennai Reporting to the Director in Singapore Supporting Singapore-based companies and start-ups Key Responsibilities: Trade and Economic Representation Sales and Project Management Business Strategy Development Trade and Regulatory Affairs Analysis Singapore Hub Strategy Advocacy Global Market Office Administration Regular travel...

Functions as the Global Product Owner (GPO) or Support GPOs for Life Cycle Management (LCM), working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections of post approval submissions. Preparation of...

Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post- approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists –CMC (GRSs-CMC) under the guidance of the team lead. The...