Sr. Regulatory Affairs Specialist (Remote PST)

Planet Pharma; United States; Remote; Full time

Job summary

A leading pharmaceutical organization is seeking a Sr. Regulatory Affairs Specialist to facilitate regulatory approvals in China and Hong Kong. The role involves creating and tracking regulatory submissions while collaborating with teams to navigate compliance and expedite approvals. Candidates must be fluent in Mandarin and possess a scientific degree with relevant regulatory experience.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 5-7 years of experience preferred, experience with China regulatory registration required.
• Strict attention to detail.
• Ability to work in a team environment.

Responsibilities

• Create regulatory submissions for China and Hong Kong affiliates.
• Provide guidance on regulatory strategies and requirements.
• Represent the regulatory function on product development teams.

Skills

Fluency in Mandarin Chinese

Microsoft Office Suite

Communication skills

Analytical skills

Problem-solving skills

Education

Bachelor's Degree in scientific discipline

Job description

Sr. Regulatory Affairs Specialist (Remote PST)

Sr. Regulatory Affairs Specialist (Remote PST)

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This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$48.00/hr - $49.00/hr

Direct message the job poster from Planet Pharma

Sr. National Recruiter @ Planet Pharma | Contract & Permanent Staffing

6 months contract

Remote - Need to be on PST time zone due to frequent later afternoon meetings with Asia regions.

**Must be fluent in Mandarin and English**

Summary:

The main function of a regulatory affairs specialist is to complete and maintain China and Hong Kong regulatory approvals and clearances of assigned products.

Key Responsibilities:

• Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by China and Hong Kong affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions

• Participate in providing guidance on strategies and contingency planning with respect to China and Hong Kong regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.

• Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.

• Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.

• Other incidental duties assigned by Leadership.

Additional Skills:

• Fluency in Mandarin Chinese

• Coursework, seminars, and/or other formal government and/or trade association training required

• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

• Good written and verbal communication skills and interpersonal relationship skills

• Good problem-solving, organizational, analytical and critical thinking skills

• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

• Solid knowledge and understanding of global regulatory requirements for new products or product changes.

• Solid knowledge of new product development systems

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

• Ability to build productive internal/external working relationships

• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education and Experience:

• Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)

• 5-7 years of experience preferred, experience with China regulatory registration required.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Other

• Industries

  Staffing and Recruiting

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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