H-1B1 Singapore Visa Regulatory Affairs Jobs
Regulatory Affairs jobs in the U.S. require a bachelor's degree in a life sciences or related field, qualifying them as H-1B1 specialty occupations. Singaporean professionals can pursue H-1B1 Singapore visa sponsorship without entering a lottery, with 5,400 annual slots that consistently go unfilled and consulate processing that skips the USCIS petition stage entirely.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Manager, Regulatory Affairs Device, works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Build and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.
Responsibilities:
- Prepares device regulatory product strategies with limited supervision.
- Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies under limited supervision.
- Develops strategies for device meetings, manages preparation for agency meetings and manages content of pre-meeting submissions under limited supervision.
- Manages products and change control with an understanding of regulations and company policies and procedures with limited supervision. Analyzes and approves manufacturing change requests with limited supervision.
- Represents Device Regulatory Affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in the regulatory climate. Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision.
- Develops, implements, and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to RA.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications
- Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management. Preferred Experience: 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing.
- Knowledge of the ISO/CE process and global product registration process. Experience with eCTD tools and EDMS applications.
- Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products.
- Understanding of device/combination product regulations.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
- Ability to travel up to 15% of time.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Manager, Regulatory Affairs Device, works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Build and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.
Responsibilities:
- Prepares device regulatory product strategies with limited supervision.
- Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies under limited supervision.
- Develops strategies for device meetings, manages preparation for agency meetings and manages content of pre-meeting submissions under limited supervision.
- Manages products and change control with an understanding of regulations and company policies and procedures with limited supervision. Analyzes and approves manufacturing change requests with limited supervision.
- Represents Device Regulatory Affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in the regulatory climate. Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision.
- Develops, implements, and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to RA.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications
- Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management. Preferred Experience: 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing.
- Knowledge of the ISO/CE process and global product registration process. Experience with eCTD tools and EDMS applications.
- Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products.
- Understanding of device/combination product regulations.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
- Ability to travel up to 15% of time.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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Get Access To All JobsTips for Finding Regulatory Affairs Jobs
Align your credentials to U.S. regulatory standards
Singaporean degrees in pharmacy, chemistry, biomedical science, or engineering are recognized for H-1B1 visa specialty occupation purposes, but your transcript must show a direct field relationship to the Regulatory Affairs role. Have an official translation and credential evaluation ready before you apply.
Target employers with active FDA submission pipelines
Pharmaceutical, medical device, and biotech companies filing NDAs, 510(k)s, or BLAs with the FDA need in-house Regulatory Affairs staff year-round. These employers are far more likely to understand H-1B1 Singapore visa sponsorship than general industry firms without U.S. market ambitions.
Search verified H-1B1 Singapore job listings on Migrate Mate
Migrate Mate filters Regulatory Affairs roles by employers with documented H-1B visa1 and H-1B LCA filing history, so you're not cold-applying to companies that have never sponsored a Singaporean professional before.
Confirm your job description satisfies specialty occupation language
Your offer letter and job description must state that a bachelor's degree in a specific field is required, not merely preferred. Vague language like 'degree or equivalent experience' can create problems at the consulate even when your credentials are strong.
Verify the prevailing wage tier before accepting an offer
Your employer's LCA must certify a wage at or above the DOL prevailing wage for your occupation code and work location. Use the OFLC Wage Search to check the applicable wage level for Regulatory Affairs roles in your target city before negotiating.
Prepare for consulate-only processing and no USCIS filing wait
Unlike H-1B, your employer doesn't file an I-129 petition with USCIS. The LCA goes to DOL, then you apply directly at the U.S. Embassy in Singapore. Coordinate your interview scheduling with your employer's LCA certification timeline to avoid gaps.
Frequently Asked Questions
Does a Regulatory Affairs role qualify as a specialty occupation under the H-1B1 Singapore visa?
Yes. Regulatory Affairs positions typically require a bachelor's degree or higher in pharmacy, chemistry, biomedical science, life sciences, or a closely related field, which satisfies the H-1B1 specialty occupation definition. Your job description must explicitly state that the degree is required, not just preferred, and the field must have a direct relationship to the duties of the role.
How does the H-1B1 Singapore visa differ from H-1B for Regulatory Affairs professionals?
The H-1B1 Singapore visa has no lottery and no USCIS petition filing, so your employer submits an LCA to DOL and you apply directly at the U.S. Embassy in Singapore. The H-1B requires a USCIS petition and subjects you to an annual lottery with roughly a 25% selection rate. For Singaporean nationals, the H-1B1 is a direct path that bypasses the lottery entirely, with 5,400 annual slots that have never been exhausted.
How do I find Regulatory Affairs employers who actually sponsor H-1B1 Singapore visas?
Migrate Mate shows Regulatory Affairs roles filtered by employers with verified LCA filing history for H-1B1 and H-1B petitions, so you can identify companies that have sponsored roles in your occupation before. Targeting employers with active FDA submission pipelines in pharma, biotech, and medical devices gives you the strongest pool of willing sponsors.
Can my employer file an H-1B1 while I'm already in the U.S. on another visa status?
H-1B1 Singapore visas are generally processed through consular processing at the U.S. Embassy in Singapore, not through a change of status filed with USCIS. If you're currently in the U.S. on F-1 OPT or another status, you would typically need to apply for the H-1B1 visa stamp at a consulate before or after your authorized stay, rather than adjusting status domestically.
What documents should I prepare before a Regulatory Affairs employer agrees to sponsor my H-1B1?
Have your academic transcripts, degree certificates, and a credential evaluation confirming field equivalency ready before the offer stage. Your employer will need these to support the specialty occupation determination in the LCA. You should also have your O*NET occupation profile for Regulatory Affairs roles printed to demonstrate the standard degree requirement for the position to any employer unfamiliar with the process.
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