Biotech & Pharma E-3 Sponsorship Jobs in Massachusetts
Massachusetts is one of the most active states for biotech and pharma E-3 visa sponsorship, anchored by the Kendall Square and Seaport District clusters in Cambridge and Boston. Major employers including Biogen, Moderna, Sanofi, and AstraZeneca regularly hire for roles that qualify as specialty occupations under E-3 requirements, making the state a strong destination for Australian life sciences professionals.
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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 for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead, works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC 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 CMC regulatory product strategies with limited supervision. Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies under limited supervision.
- Responds to global regulatory information requests under limited supervision.
- Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages, under limited supervision.
- Manages products and change control with an understanding of regulations, agency guidance and company policies and procedures with limited supervision. Analyzes and approves manufacturing change records with limited supervision.
- Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment.
- Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision.
- Contributes to creation of white papers and policies to illustrate current regulatory thinking under supervision of manager. Participates in initiatives internal to RA CMC.
- May act as a formal or informal mentor to others.
- This position will work a hybrid work schedule (3 days in office) from the AbbVie Lake County, IL; Irvine, CA or Waltham, MA headquarters.
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.
- Preferred Education: Relevant advanced degree preferred. Certification a plus.
- Required Experience: 6 years biopharmaceutical or related industry experience.
- Preferred Experience: 6 years biopharmaceutical RA, R&D or Operations experience including 3 years in regulatory affairs.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
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 for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead, works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC 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 CMC regulatory product strategies with limited supervision. Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies under limited supervision.
- Responds to global regulatory information requests under limited supervision.
- Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages, under limited supervision.
- Manages products and change control with an understanding of regulations, agency guidance and company policies and procedures with limited supervision. Analyzes and approves manufacturing change records with limited supervision.
- Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment.
- Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision.
- Contributes to creation of white papers and policies to illustrate current regulatory thinking under supervision of manager. Participates in initiatives internal to RA CMC.
- May act as a formal or informal mentor to others.
- This position will work a hybrid work schedule (3 days in office) from the AbbVie Lake County, IL; Irvine, CA or Waltham, MA headquarters.
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.
- Preferred Education: Relevant advanced degree preferred. Certification a plus.
- Required Experience: 6 years biopharmaceutical or related industry experience.
- Preferred Experience: 6 years biopharmaceutical RA, R&D or Operations experience including 3 years in regulatory affairs.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
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
E-3 Biotech & Pharma Job Roles in Massachusetts
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Search Biotech & Pharma Jobs in MassachusettsBiotech & Pharma E-3 Sponsorship Jobs in Massachusetts: Frequently Asked Questions
Which biotech and pharma companies sponsor E-3 visas in Massachusetts?
Several large and mid-size employers in Massachusetts have established E-3 visa sponsorship track records, including Biogen, Moderna, Sanofi, AstraZeneca, Takeda, and Vertex Pharmaceuticals. Many clinical-stage biotechs headquartered in Cambridge and Boston also sponsor E-3 visas, though sponsorship willingness varies by role, headcount, and hiring cycle. Checking recent Labor Condition Application filings on the DOL OFLC disclosure database can confirm which employers have filed for E-3 workers.
Which cities in Massachusetts have the most biotech and pharma E-3 sponsorship jobs?
Cambridge and Boston together form the densest biotech and pharma hiring market in Massachusetts, particularly around Kendall Square, the Longwood Medical Area, and the Seaport District. Waltham and Lexington host a significant number of established pharma and contract research organizations. Worcester has a growing life sciences presence tied to its academic medical institutions. The vast majority of E-3 sponsorship opportunities in the state are concentrated in the Greater Boston corridor.
What types of biotech and pharma roles typically qualify for E-3 sponsorship?
E-3 sponsorship requires the role to qualify as a specialty occupation, meaning it must normally require at minimum a bachelor's degree in a specific field. In biotech and pharma, positions commonly meeting this standard include research scientists, bioinformaticians, clinical research associates, regulatory affairs specialists, biostatisticians, pharmacovigilance analysts, and process development engineers. Roles where any degree field is acceptable, or where experience substitutes freely for a degree requirement, are less likely to qualify.
How do I find biotech and pharma E-3 sponsorship jobs in Massachusetts?
Migrate Mate is built specifically for this search, letting you filter by visa type, state, and industry to surface biotech and pharma roles with E-3 sponsorship in Massachusetts. Because E-3 sponsorship is employer-driven, targeting companies with a demonstrated history of LCA filings in life sciences gives you better odds than applying broadly. Migrate Mate aggregates these opportunities so you are not manually sifting through listings that will not support your visa.
Are there any Massachusetts-specific or industry-specific considerations for E-3 sponsorship in biotech and pharma?
Massachusetts has a highly competitive life sciences hiring market, which generally works in favor of international candidates with specialized skills. However, smaller biotechs and early-stage startups may lack prior experience with E-3 sponsorship processes, so be prepared to provide employers with information about the visa category. The state's concentration of academic medical centers and research hospitals also creates a distinct set of employers, some of which hold cap-exempt H-1B visa status, though E-3 applications are handled through consular processing regardless.
What is the prevailing wage for E-3 biotech & pharma jobs in Massachusetts?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.