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Regulatory Strategy Jobs (NOW HIRING)

Lundbeck

Senior Manager Regulatory Strategy

Deerfield, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Evanston, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Chicago, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Schaumburg, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Palatine, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Lake Villa, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Deerfield, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Great Lakes, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Island Lake, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Russell, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Chicago, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Northbrook, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

Lundbeck

Senior Manager Regulatory Strategy

Wadsworth, IL · On-site

$165K - $185K/yr

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological ...

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Regulatory Strategy information

See salary details

$40.5K

$95.4K

$138.5K

How much do regulatory strategy jobs pay per year?

As of Aug 9, 2026, the average yearly pay for regulatory strategy in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

What is regulatory strategy?

Regulatory strategy refers to the planning and management of processes to ensure that a company's products or services comply with applicable laws, regulations, and industry standards. This often involves working with regulatory agencies, preparing and submitting documentation, and staying updated on regulatory changes that could impact the business. Professionals in regulatory strategy play a critical role in guiding companies through approval processes, minimizing compliance risks, and ensuring timely entry into markets. Their expertise helps organizations navigate complex regulatory landscapes efficiently and effectively.

What are the key skills and qualifications needed to thrive in regulatory strategy?

Success in Regulatory Strategy requires a strong understanding of regulatory frameworks, compliance processes, and strategic planning, often supported by a degree in life sciences, law, or a related field. Familiarity with regulatory submission systems, databases, and certifications like RAC (Regulatory Affairs Certification) is common. Excellent analytical thinking, communication, and negotiation skills set outstanding professionals apart in this field. These competencies are crucial for ensuring that products meet regulatory requirements efficiently, enabling timely market access and reducing compliance risks.

What are some common challenges faced in a regulatory strategy role, and how can they be addressed?

Professionals in Regulatory Strategy often navigate complex and evolving regulatory environments, which can make it challenging to keep up with changing requirements across multiple regions. Balancing business goals with regulatory compliance sometimes requires creative problem-solving and effective stakeholder communication. To address these challenges, it's important to stay informed through continual training, foster strong relationships with regulatory authorities, and collaborate closely with cross-functional teams such as R&D, legal, and quality assurance. This proactive approach helps ensure that strategic objectives are met while maintaining compliance.

What is the difference between Regulatory Strategy vs Regulatory Affairs?

AspectRegulatory StrategyRegulatory Affairs
Primary FocusDeveloping long-term plans to meet regulatory requirements and facilitate product approvalManaging day-to-day regulatory submissions, compliance, and communication with authorities
Work EnvironmentStrategic planning, cross-functional collaboration, market entry planningDocumentation, submission management, regulatory compliance activities
Required CredentialsTypically advanced degrees in life sciences, regulatory affairs certificationsSimilar credentials, often with regulatory affairs certifications

Regulatory Strategy focuses on planning and aligning regulatory pathways for product approval, while Regulatory Affairs handles the execution of these plans through submissions and compliance activities. Both roles require similar qualifications but differ in scope and daily responsibilities.

More about Regulatory Strategy jobs
What cities are hiring for Regulatory Strategy jobs? Cities with the most Regulatory Strategy job openings:
What are the most commonly searched types of Regulatory Strategy jobs? The most popular types of Regulatory Strategy jobs are:
What states have the most Regulatory Strategy jobs? States with the most job openings for Regulatory Strategy jobs include:
What job categories do people searching Regulatory Strategy jobs look for? The top searched job categories for Regulatory Strategy jobs are:
Regulatory Strategy jobs near you
Infographic showing various Regulatory Strategy job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Director, Regulatory Strategy - Global Regulatory Lead

Beeline Medicines

Boston, MA • On-site

$163K - $215K/yr

Full-time

PTO

Re-posted 17 days ago

Job description

About Beeline Medicines:
Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully.
Job Summary:
The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for the company's early-stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with a particular focus on lupus and adjacent autoimmune indications. This role serves as the primary regulatory strategist and Health Authority relationship lead for pre-IND through Phase II clinical programs, guiding development teams in the design of regulatory-sound development plans, optimal filing strategies, and early Health Authority engagement. The Director provides a global perspective across FDA, EMA, and other major regulatory jurisdictions, ensuring that regulatory strategy is proactively integrated into all aspects of early clinical and translational development. As a key member of the Regulatory Affairs team, this individual also contributes to the development of the company's regulatory infrastructure, capabilities, and organizational best practices for pipeline program oversight.
Work Arrangement & Location:
Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.
Essential Duties and Responsibilities:
  • Develop and lead integrated global regulatory strategies for assigned pipeline programs in the I&I portfolio, encompassing pre-IND planning, IND/CTA submission strategy, Phase I/II/III development planning, and regulatory pathway optimization across major global jurisdictions including FDA, EMA, PMDA, and others.
  • Serve as the primary regulatory strategist for assigned program teams, providing expert guidance on development plan design, regulatory risk identification, filing sequencing, and Health Authority engagement strategy.
  • Lead the preparation and execution of regulatory meetings, including management of timelines, briefing document development, strategic meeting preparation, and agency interaction management; translate Health Authority feedback into actionable development recommendations.
  • Develop and maintain integrated regulatory development plans (iRDPs) and regulatory timelines for all assigned programs, ensuring alignment with clinical, CMC, and non-clinical development activities and overall program milestones.
  • Lead IND and CTA, NDA and BLA submissions, regulatory planning and submission of pediatric development plans.
  • Provide strategic input to clinical protocols, non-clinical study designs, and early CMC development activities to ensure regulatory acceptability and alignment with global development strategy.
  • Monitor and interpret evolving FDA and global regulatory guidance, precedent regulatory decisions, and competitive landscape intelligence relevant to I&I development programs, and proactively integrate insights into pipeline regulatory strategy.
  • Evaluate and leverage expedited regulatory pathway opportunities for pipeline programs, including Breakthrough Therapy Designation (BTD), Fast Track Designation, PRIME designation (EMA), and Orphan Drug Designation where applicable.
  • Partner with Regulatory Affairs CMC, Clinical Development, Non-Clinical Sciences, Bioanalytics, and Translational Sciences teams to ensure that cross-functional development activities are regulatory-strategy aligned from the earliest stages of development.
  • Contribute to regulatory due diligence activities for pipeline asset evaluations, in-licensing candidates, and business development targets, assessing regulatory risk profiles, development pathway viability, and filing readiness.
  • Maintain appropriate trackers of regulatory activities.
  • Concise, clear and frequent communication with cross functional team. This position requires maturity, finesse and leadership to lead the cross-functional team, and high level of strategic acumen and finesse to define and lead regulatory interactions.
  • Assess resource needs to support the assigned programs and with manager, participate in the development of the budget for assigned programs
  • Perform other duties and responsibilities as assigned.

Qualifications:
  • Education: Advanced degree (PhD, PharmD, or master's level) in a relevant life sciences discipline required.
  • Minimum of 10+ years of regulatory affairs experience in the pharmaceutical or biotech industry, with at least 5 years of direct responsibility for global regulatory strategy leadership on clinical development programs preferred.
  • Deep expertise in global regulatory strategy development for biologics and/or small molecule therapeutics, with demonstrated experience developing regulatory plans across FDA, EMA, and additional global jurisdictions from pre-IND through post approval.
  • Extensive experience preparing and leading Health Authority interactions, including FDA pre-IND, Type B, and Type C meetings and EMA Scientific Advice meetings, with a strong track record of productive agency relationships and strategic translation of feedback.
  • Thorough knowledge of FDA regulations (21 CFR Parts 312 and 314/601), EMA regulatory frameworks, ICH E8(R1), ICH E9(R1), and applicable guidance documents relevant to early clinical development in I&I or autoimmune disease indications.
  • Prior experience in immunology, inflammation, autoimmune disease, or a related therapeutic area is strongly preferred; knowledge of lupus regulatory landscape and precedent regulatory decisions is a meaningful advantage.
  • Strong strategic thinking skills, intellectual curiosity, and the ability to synthesize complex scientific and regulatory information into clear, actionable regulatory development recommendations.
  • Demonstrated ability to operate independently, driving execution of regulatory plans with agility and efficiency, while exercising sound judgment in stakeholder engagement, including proactively keeping leadership appropriately informed and involving senior management at key decision points.
  • Able to manage multiple concurrent priorities with focus, efficiency, and sound judgment, balancing competing timelines and development milestones in a matrix biotech organization, with an appreciation for the visibility and criticality of programs in a small-company environment.
  • Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners.
  • Demonstrated ability to communicate operational information into clear, actionable insights, providing decisive direction to teams and driving efficient, aligned execution across functions.
  • Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies.

Salary Range:
The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.
Salary Range
$211,500-$258,500 USD
Benefits:
We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:
  • Competitive health and wellness coverage (structure and premiums vary by country)
  • Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
  • Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.
Equal Employment Opportunity:
Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Reasonable Accommodation:
If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.
PrivacyUpon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines

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