Regulatory Affairs Lead Green Card Jobs
Regulatory Affairs Lead roles qualify for EB-2 or EB-3 green card sponsorship through PERM labor certification, which permanently authorizes foreign professionals to work in the U.S. Employers file on your behalf, covering regulatory strategy, submissions management, and compliance oversight. Finding employers with active PERM filing history is the first step toward permanent residency sponsorship.
See All Regulatory Affairs Lead JobsOverview
Showing 5 of 11+ Regulatory Affairs Lead jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 11+ Regulatory Affairs Lead jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Lead roles.
Get Access To All JobsCompany Description
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.
Job Description
Role Summary/Purpose:
- The Regulatory Affairs Leader - Pharma may be involved in Pre or Postmarket duties or both.
- He/she provides subject matter expertise and works with a team of RA professionals to ensure establishes best practices in premarket & postmarket for RA, and ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country.
Essential Responsibilities
- File / Maintain regulatory deliverables.
- Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies.
- Support local regulatory authority / notified body inspections as required.
- Educate, train, & advise company professionals to ensure compliance with regulatory requirements.
- Coach and mentor other RA professionals.
Premarket:
- Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions.
- Communicate with Product RA resources to establish regulatory requirements, including clinical trial data.
- Provide RA support as needed to clinical studies to ensure regulatory requirements are met.
- Partner with Product RA professionals to review advertising and promotion materials for country or regional compliance and approve these as required.
- Act as liaison with external regulatory reviewers to gain rapid approval of submissions.
- Work with appropriate Product RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license.
- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes.
Postmarket:
- Reviews new reportable adverse events for country reportability.
- Prepare Recall submissions, localize if applicable.
- Prepare Regulatory Authority responses to inquiries; work with the P&L to ensure accurate response.
- Following PSRB decision, review field action information to determine if reportable in local country.
- Support regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes.
- Act as liaison with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.
- Provide evidence of official closure of postmarket actions (e.g. AERs and Recalls) to the P&L.
- Monitor external information for incidents or issues that may involve product; communicate information internally in a timely manner.
Quality Specific Goals:
- Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
- Complete all planned Quality & Compliance training within the defined deadlines.
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility.
- Effectively support implementation & management of current regulatory requirements within area of responsibility.
- Ensure assigned regulatory submissions are accurate, complete and timely NEHPP.
Qualifications
Qualifications/Requirements
- Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical or biotechnology industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in pharmaceutical or biotechnology industry or with regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls.
- Ability to prioritize, plan & evaluate deliverables to established strategic goals.
- Proven application of analytical skills in a regulatory environment.
- Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
- Strong problem solving and negotiation skills.
- Ability to work well independently & in a team setting.
- Prior experience using spreadsheet and presentation software.
- Must be willing to travel up to 10% of time.
Desired Characteristics
- IND, NDA or related submission experience.
- Regulatory Affairs Certification (RAPS).
- Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
- Knowledge of Quality Management Systems (QMS).
- Experience with working across cultures/countries/sites.
- Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
- Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies.
- Experience with adverse event reporting and recalls.
- Orphan drug or generics experience.
Additional Information
If you are interested and want to apply, Please contact:
Ujjwal Mane
973-805-7557
ujjwal.mane(at)collabera.com
Company Description
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.
Job Description
Role Summary/Purpose:
- The Regulatory Affairs Leader - Pharma may be involved in Pre or Postmarket duties or both.
- He/she provides subject matter expertise and works with a team of RA professionals to ensure establishes best practices in premarket & postmarket for RA, and ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country.
Essential Responsibilities
- File / Maintain regulatory deliverables.
- Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies.
- Support local regulatory authority / notified body inspections as required.
- Educate, train, & advise company professionals to ensure compliance with regulatory requirements.
- Coach and mentor other RA professionals.
Premarket:
- Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions.
- Communicate with Product RA resources to establish regulatory requirements, including clinical trial data.
- Provide RA support as needed to clinical studies to ensure regulatory requirements are met.
- Partner with Product RA professionals to review advertising and promotion materials for country or regional compliance and approve these as required.
- Act as liaison with external regulatory reviewers to gain rapid approval of submissions.
- Work with appropriate Product RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license.
- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes.
Postmarket:
- Reviews new reportable adverse events for country reportability.
- Prepare Recall submissions, localize if applicable.
- Prepare Regulatory Authority responses to inquiries; work with the P&L to ensure accurate response.
- Following PSRB decision, review field action information to determine if reportable in local country.
- Support regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes.
- Act as liaison with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.
- Provide evidence of official closure of postmarket actions (e.g. AERs and Recalls) to the P&L.
- Monitor external information for incidents or issues that may involve product; communicate information internally in a timely manner.
Quality Specific Goals:
- Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
- Complete all planned Quality & Compliance training within the defined deadlines.
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility.
- Effectively support implementation & management of current regulatory requirements within area of responsibility.
- Ensure assigned regulatory submissions are accurate, complete and timely NEHPP.
Qualifications
Qualifications/Requirements
- Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical or biotechnology industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in pharmaceutical or biotechnology industry or with regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls.
- Ability to prioritize, plan & evaluate deliverables to established strategic goals.
- Proven application of analytical skills in a regulatory environment.
- Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
- Strong problem solving and negotiation skills.
- Ability to work well independently & in a team setting.
- Prior experience using spreadsheet and presentation software.
- Must be willing to travel up to 10% of time.
Desired Characteristics
- IND, NDA or related submission experience.
- Regulatory Affairs Certification (RAPS).
- Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
- Knowledge of Quality Management Systems (QMS).
- Experience with working across cultures/countries/sites.
- Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
- Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies.
- Experience with adverse event reporting and recalls.
- Orphan drug or generics experience.
Additional Information
If you are interested and want to apply, Please contact:
Ujjwal Mane
973-805-7557
ujjwal.mane(at)collabera.com
See all 11+ Regulatory Affairs Lead jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Lead roles.
Get Access To All JobsTips for Finding Green Card Sponsorship in Regulatory Affairs Lead
Document your regulatory credentials strategically
Gather degree transcripts, professional certifications like RAC, and performance reviews that demonstrate scope of regulatory submissions managed. PERM labor certification requires your employer to prove your qualifications match the role's minimum requirements exactly.
Target employers with active PERM filing history
Pharmaceutical, biotech, and medical device companies with dedicated regulatory affairs departments file PERM petitions regularly. Use Migrate Mate to filter Regulatory Affairs Lead roles by employers with documented green card sponsorship activity.
Understand EB-2 versus EB-3 classification for your background
If you hold a master's degree in a life sciences or regulatory field, you likely qualify for EB-2, which can mean shorter green card wait times for many nationalities. EB-3 covers bachelor's-level professionals and has no annual cap issues for most countries.
Verify specialty occupation alignment before accepting offers
Regulatory Affairs Lead roles typically qualify as specialty occupations under O*NET, requiring specialized knowledge of FDA or international regulatory frameworks. Confirm your job description explicitly references submission management or agency interaction to support the PERM filing.
Request employer-sponsored PERM early in offer negotiations
Once PERM is filed, your priority date locks in, protecting your place in the green card queue even if processing takes years. Raising sponsorship during offer negotiation, before you start, gives the employer time to begin DOL prevailing wage determination without delaying your start date.
Use OFLC Wage Search to benchmark your offer
DOL requires PERM-sponsored employers to pay the prevailing wage for your role and location. Cross-check your offered salary against the OFLC Wage Search before signing, since an offer below the DOL Level II or III threshold can invalidate the entire PERM filing.
Regulatory Affairs Lead jobs are hiring across the US. Find yours.
Find Regulatory Affairs Lead JobsRegulatory Affairs Lead Green Card Sponsorship: Frequently Asked Questions
Does a Regulatory Affairs Lead role qualify for EB-2 or EB-3 green card sponsorship?
Most Regulatory Affairs Lead positions qualify for both EB-2 and EB-3 depending on your degree level and your employer's job requirements. EB-2 applies when the role formally requires an advanced degree, which many senior regulatory positions do. EB-3 covers roles requiring at least a bachelor's degree. Your employer's attorney typically determines the classification based on the actual job description filed with DOL.
How does PERM green card sponsorship differ from H-1B for this role?
H-1B is a temporary nonimmigrant status requiring renewal every three years, with no guarantee of renewal and exposure to the annual lottery at the cap-subject level. PERM-based green card sponsorship leads to permanent residency with no status expiration. There is no annual lottery for employment-based green cards, and EB-3 has no cap on the number of applications, only on annual visa issuance per country. Regulatory professionals from most countries face shorter waits at the EB-3 level than Indian or Chinese nationals at EB-2.
How do I find Regulatory Affairs Lead jobs where the employer will sponsor a green card?
Search Migrate Mate to filter Regulatory Affairs Lead openings by employers with verified PERM sponsorship history. Not every job posting advertises green card sponsorship, so filtering by actual DOL filing records gives you a more reliable signal than relying on job descriptions alone. Pharmaceutical, medical device, and biotech companies with U.S. regulatory teams are the most active PERM filers in this occupation.
What does the PERM labor certification process look like for a Regulatory Affairs Lead?
Your employer must conduct a supervised recruitment process proving no qualified U.S. workers are available for the role at the offered wage. DOL reviews the application and, if certified, your employer files Form I-140 with USCIS to establish your immigrant visa petition. Current PERM processing at DOL runs several months for standard cases, and USCIS I-140 adjudication adds additional time. Your priority date is set when DOL receives the PERM application.
Can I change jobs after my employer files a PERM petition for my Regulatory Affairs Lead role?
Changing employers before your I-140 is approved generally restarts the PERM process with the new employer. Once your I-140 is approved and your priority date is more than 180 days old, federal law allows you to port to a same or similar regulatory affairs role with a new employer without losing your priority date. USCIS evaluates whether the new role is sufficiently similar to the original petition to allow portability.
See which Regulatory Affairs Lead employers are hiring and sponsoring visas right now.
Search Regulatory Affairs Lead Jobs