Regulatory Affairs Specialist (8-10 years of experience) with an Hourly Rate below $100 in Argentina, Cambodia, Croatia, Hong Kong, India, Indonesia, Kenya, Malaysia, Myanmar, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Tanzania, Thailand, Turkey, UAE, Uzbekistan, Vietnam

Regulatory Affairs Specialist (8-10 years of experience) with an Hourly Rate below $100 in Argentina, Cambodia, Croatia, Hong Kong, India, Indonesia, Kenya, Malaysia, Myanmar, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Tanzania, Thailand, Turkey, UAE, Uzbekistan, Vietnam

Pattern of USA Inc. has been short-listed as a centralized supplier of common regulatory affairs services for a major international corporation. This presents a significant opportunity for a long-term contract encompassing upcoming projects from several affiliated companies. Similar to our successful pharmacovigilance project, we are moving forward with ready-to-use hourly rates. This initiative is not merely an information-gathering exercise; it will directly lead to Master Service Agreement (MSA) and actual orders in the coming years.

To streamline the submission process, please complete our 3-minute survey. The survey asks for your name, affiliated company, communication preferences, hourly rates (separated by Life Science category), and the countries you can assist with. To ensure accurate categorization, please choose one category and/or one country per submission. If you wish to submit for additional categories or countries, please complete a separate form for each.

Click here to start your submission: https://forms.gle/cQVYyucsPXfSxDGf7

The survey consists of four key sections:

• Contact Information: Details about yourself as the primary contact.
• Yes-or-No RA Questions: Focuses on common regulatory affairs services for pharmaceuticals and medical devices. We recommend confirming your ability to cover all topics by answering “Yes.”
• Yes-or-No CMC Questions: Pertains to more sophisticated regulatory affairs services. Please note that in most cases, you won’t be required to develop documents from scratch; this section primarily addresses local adaptation of services, form completion, and communication with National Regulatory Authorities (NRAs).
• Hourly Rates: Enter your hourly rate based on your years of experience. If you are part of a company, please include all possible job titles to provide a comprehensive range. We will delve deeper into these rates if you or your company is short-listed. Ensure your rates increase proportionally with years of experience.

Tips for a Successful Submission and Short-listing:

• One Submission Per Company for the same Life Science Category and Country: Please do not submit multiple surveys for employees of the same company. Each company has a limit of one response per Category and Country, but you will be able to adjust your answers before the submission deadline on June 27th, 2025.
• Payment Terms: Due to the complex schedule of validations, approvals, and international payment releases, and in accordance with client policy, all service payments will be made 90 days after the SOW acceptance. This does not affect pass-through payments for Powers of Attorney (POAs), legal documents, official fees, etc.
• Quality and Compliance: You will be required to follow our Quality Management System (QMS) and Standard Operating Procedures (SOPs) for processing and communication, aligning with Pattern of USA Inc.’s standards and client policy. Internal audits will be required for any initiated projects.
• Competitive Pricing: To increase your chances of being short-listed, please keep your hourly rates as low as possible and consider offering a partnership discount. This is an open procurement process, and your expertise will be weighed against that of other suppliers from various countries. Budget allocation will be a crucial factor for the client. Your quotes will be anonymized and kept confidential, preventing horizontal data leaks; this information is exclusively between you and Pattern of USA Inc.
• NDA Option: If you prefer to execute a Non-Disclosure Agreement (NDA) before submission, and if one has not already been signed by you and Pattern of USA Inc., please download, revise, sign, and submit it to my email Vladislav_Reznikov@PatternOfUSA.com: https://drive.google.com/file/d/1SeCoyhK_o7TpmrlCodXQ0JSS64v0GPH_/view?usp=share_link
• Assistance Available: Should you require a “friendly hand” to complete the questionnaire, please arrange a virtual meeting via Zoom at your convenience: https://calendly.com/patternofusa/intro. Please note that no further project details are available beyond what is provided in the questionnaire.

Below is a list of common regulatory affairs abbreviations used in the survey.