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Manager, Global Labeling

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Associate Principal Engineer

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Experienced leader with 20 years’ experience in Information Technology, Management Consulting, Business Transformation, Program Management Risk Management and Change Management. Passionate people leader, effective in building and growing high performing and Diversity teams. I enjoy working with people of different backgrounds and professional experience. I have a proven track record in Technology, Strategy, Business Transformation, Program Management and People Management. My experience cuts across Technology Leadership, Business Partnering, Program Management and Consulting. I have led a global Technology teams, Service Delivery Managers and IT Business partners. I have also successfully worked and advised Executive corporate business leaders, and their direct reports in Finance, Procurement, Legal, Compliance, Communications and Human Resources. I worked for a life science company for 16 years where I was promoted into several roles as a result overachieving or achieving my targets and Company Objectives mainly in Financials, People Management and Service Delivery. Currently i am a Heading a Corporate Functions Technology at Sandoz where i have successfully built the team from scratch. From 0 to 150 associates both internal and external to support different business functions. I previously worked for 2 Big four consulting companies mainly Deloitte and KPMG. I have a degree in Information Technology and Economics from Albstadt Sigmaringen University, Germany, enriched with leadership and Business Strategy courses at IMD Business School Switzerland, Babson college in Boston USA and Oxford University in the UK.

Experienced financial analyst and management Postgrad with 4 years' finance domain expertise. Proficient in assessing financial data, conducting comprehensive research, and delivering precise analysis. Skilled in financial statement analysis, trend identification, and risk mitigation. Strong attention to detail, problem-solving abilities, and dedicated to driving business growth.

Commerciale expérimentée (25 années) - Autonome- Sens du relationnel - Connaissance professionnelle du milieu hospitalier et du bloc opératoire

Dynamic regulatory affairs professional with extensive experience at Viatris, specializing in U.S. and EU labeling compliance. Proven track record in ensuring FDA and EMA adherence, while enhancing data accuracy and documentation control. Adept at cross-department collaboration, leveraging strong communication skills to drive successful product labeling initiatives.

Dynamic Global Regulatory Affairs Specialist II at Thermo Fisher Scientific Inc. with a proven track record in regulatory assessment and process improvement. Expert in data management and cross-functional collaboration, successfully enhancing NPI workflows and mitigating compliance risks. Recognized for leadership, problem-solving abilities, and training initiatives that foster team productivity and data integrity.

Regulatory Affairs Specialist with experience at AbbVie Inc., focusing on compliance and global submissions. I possess an expertise in regulatory documentation and cross-functional collaboration which has driven significant process improvements and enhanced submission efficiency. My strong analytical and communication skills facilitate successful product approvals, complemented by a commitment to staying updated on legal regulations for continuous compliance.

I am a results-oriented professional renowned for my proficiency in quality assurance, manufacturing operations, and process enhancement, boasted over a decade of experience in the pharmaceutical and biotechnology sectors. My adeptness lies in ensuring meticulous adherence to industry standards and regulatory protocols. Having overseen the production of regulatory starting materials, intermediates, and API to meet clinical trial material requisites and facilitate commercial process validation, I demonstrate exemplary leadership. I possess a commendable track record in instituting and upholding resilient quality control mechanisms. I have collaborated closely with QC Microbiology, managing bioburden samples and TSA plate samples. Charged with the aseptic processing of clinical and commercial phase products adhering to cGMP standards, I executed my responsibilities with precision. I conducted testing of raw materials, in-process materials, and formulation samples to bolster production efforts. I storied career includes adept management of quality control processes, ensuring the delivery of high-Caliber products in alignment with regulatory requisites. With oversight of the directional flow of deviations, investigations, root causes, CAPAs, and their timely closures, I ensure efficiency and effectiveness. I am a local candidate and is available to start on 2 weeks’ prior notice. Start-up experience including OQ and PQ. Perform daily operations associated with large scale cell culture up to 20,000L production bioreactor. Possess a working knowledge of bioreactors, continuous flow centrifuge and depth filtration equipment.

Detail-focused, highly-motivated with extensive experience in overseeing quality control, quality inspection and quality assurance with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills.

Driven Pharmacy Technician and Laboratory specialist with proven track record and success in building strong relationships with patients and clients. Detail-oriented with a commitment to maintaining high-quality assurance and control standards when filling prescriptions. Capable pharmacy team member proficient in assisting pharmacists with preparing prescriptions and meeting customer needs. Safety-oriented and well-organized with solid experience coordinating with insurance providers, prescribers and individuals to address issues. Good relationship-building and multitasking skills. Experienced Pharmacy Technician knowledgeable in all facets of pharmacy operations, eager to bring talent and expertise to CVS Pharmacy. Successful in quickly and accurately filling prescription orders and building relationships with customers for sustained business growth and customer retention. Team-oriented and dedicated to collaboratively delivering exceptional customer service. Driven Pharmacy Technician with 2 years of experience and success in working within fast-paced pharmacy settings. Highly proficient in accurately filling and labeling prescriptions, maintaining drug inventories and updating pharmacy records. Excited to bring talent and record of excellence in customer service to growing pharmacy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Accomplished and certified Pharmacy Technician with over 2 years of experience in retail pharmacy environments for major national chains. Practiced at offering medications to patients, offering information to patients and communicating with healthcare professionals. Knowledgeable about FDA drug safety guidelines, prescription interactions and pharmacy law. Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level in all my position. Ready to help team achieve company goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Seasoned Area Supervisor dedicated to streamlining operations and maximizing team performance. Driven to improve processes and reduce costs with hands-on management style. Bringing strong communication, planning and problem solving abilities demonstrated over 5 years in the field. Motivated Area Supervisor versed in community relations, and teaching doctor's in new surgical procedures all of the united states in the United Tissue Network while also appareling ion natation television. Highly effective at training staff, maximizing productivity and controlling inventory. Experienced production leader knowledgeable about medical practices and regulatory requirements. Directs and motivates employees to accomplish challenging performance and quality objectives. Successful at keeping costs low and employee job satisfaction high while promoting safety and compliance. Delivered supplies and equipment to departments by receiving and transferring items. Maintained inventory and reconciled variances by conducting regular physical counts. Innovative in my expertise as a laboratory technician ready to bring 5 years of relevant work experience to new position. Fully invested in overseeing all aspects of logistical operations. Accurate and collaborative individual with documented success in resolving inventory issues and medical machine operations. Encouraging manager and analytical problem-solver with talents for team building, leading and motivating, as well as excellent customer relations aptitude and relationship-building skills. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success. Hardworking and passionate job seeker with strong organizational skills eager to secure laboratory position. Ready to help team achieve company goals.

Divya Sattiraju

Summary

Overview

Work History

Global Labeling Specialist (Regulatory Affairs)

Drug Safety Associate

Internship Student

Education

Doctor of Pharmacy (PharmD) -

Skills

Certification

Timeline

Global Labeling Specialist (Regulatory Affairs)

Drug Safety Associate

Internship Student

Doctor of Pharmacy (PharmD) -

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