Senior Regulatory Affairs Specialist (Remote) (EST/PST Time)
Summary: The Senior Regulatory Affairs Specialist role is a fully remote position focused on ensuring compliance with national and global regulations in the pharmaceuticals or diagnostics industry. The candidate will develop and implement regulatory programs, support product integration activities, and manage submissions and renewals. This position requires a strong background in regulatory affairs, with a minimum of four years of relevant experience. The role is contract-based for 12-18 months and requires working on EST/PST time zones.
Key Responsibilities:
- Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
- Regulatory support for integration activities including reviews of product labeling and marketing materials for accuracy and compliance with regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
- Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
- Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
- Responds to customers’ and/or authorities’ requests/inquiries dealing with regulations and product compliance.
- Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
Key Skills:
- Bachelor's or master's Degree or equivalent.
- Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics.
- Typically, at least 4+ years relevant experience for entry into this level.
- Post-graduate certification and/or license may be required.
Salary (Rate): undetermined
City: undetermined
Country: undetermined
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Detailed Description From Employer:
Please note that this is a 12-18 Month Contract position, is Fully Remote and the candidate must work on EST/PST.
JOB DESCRIPTION:
Qualifications:
- Bachelor''''''''s or master''''''''s Degree or equivalent.
- Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics
- Typically, at least 4+ years relevant experience for entry into this level.
- Post-graduate certification and/or license may be required.
Responsibilities:
- Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
- Regulatory support for integration activities including reviews of product labeling and marketing materials for accuracy and compliance with regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
- Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
- Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
- Responds to customers’ and/or authorities’ requests/inquiries dealing with regulations and product compliance.
- Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
Candidates must provide their phone number. Job reference number is A5387.
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