Senior Regulatory Affairs Consultant Job at Product Life Group

Head of Regulatory Affairs Americas

We're making the world of digital assets accessible and secure for everyone. Joi...

Location

United States , Miami, Florida

Salary:

Not provided

Ledger

Expiration Date

Until further notice

Requirements

Minimum 8 years experience at a financial regulatory agency or policymaking body, or covering regulatory topics in the legal, fintech, or financial services sectors
Prior crypto industry experience a plus
Knowledgeable about blockchain technology and the US and Latin America crypto-asset regulatory landscape
Knowledgeable about US and Latin American financial regulations, such as those applicable to crypto-asset service providers, payment services providers, E-money institutions, banks and custodians, securities and financial instrument issuers, and trading platforms
Specific knowledge of AML/CFT and financial sanctions law and international standards is desirable
Ability to quickly learn and adapt to new regulatory subject matters and jurisdictions
Proven relationships with key stakeholders, such as those at regulatory agencies and international bodies, legislatures, and central banks
Fluency in English required
fluency in Spanish is strongly desired
Exceptional communication skills, both written and verbal

Job Responsibility

Build and maintain subject matter expertise of the changing regulatory landscape in the areas of digital assets, financial services and capital markets
Advise business units and senior leadership on the development and adaptation of products, business lines and business models in light of existing or anticipated regulatory requirements
Define and execute strategies to proactively influence the development of favorable digital asset regulation in North and South America
Coordinate with the Global Head of Policy on identifying and reacting to significant public policy challenges and opportunities with respect to Ledger’s business priorities
Build strong relationships with other regulatory professionals in the digital asset and traditional finance ecosystems, as well as with relevant governmental authorities and multinational bodies
Lead the development of Ledger’s responses to regulatory proposals, solicitations and consultations
Lead the response of Ledger to regulatory inquiries, examinations or investigations, and contribute to crisis response teams as assigned
Represent Ledger’s perspective on regulatory policy through public speaking and written thought leadership
Assist the Global Head of Policy in managing outside consultants and membership organisations

What we offer

Training: Get trained and gain experience in one of today's most exciting and growing industries
Equity: Employees are the foundation of our success, and we award stock options so you can share in that success as we grow
Medical: Comprehensive health insurance policy offering extensive medical, dental and vision care coverage
Well-being: Personal development, coaching & fitness with our dedicated partners
Vacation: 20 days of paid leave per year
Retirement: 401k with employer match
High tech: Access to high performance office equipment and gadgets, including Apple products
Transport: Ledger reimburses part of your preferred means of transportation
Discounts: Employee discount on all our products

Fulltime

Head of Regulatory Affairs Americas

As Head of Regulatory Affairs for the Americas, you will report to the Global He...

Location

United States , Washington, District of Columbia

Salary:

Not provided

Ledger

Expiration Date

Until further notice

Requirements

Minimum 8 years experience at a financial regulatory agency or policymaking body, or covering regulatory topics in the legal, fintech, or financial services sectors. Prior crypto industry experience a plus
Knowledgeable about blockchain technology and the US and Latin America crypto-asset regulatory landscape
Knowledgeable about US and Latin American financial regulations, such as those applicable to crypto-asset service providers, payment services providers, E-money institutions, banks and custodians, securities and financial instrument issuers, and trading platforms
Specific knowledge of AML/CFT and financial sanctions law and international standards is desirable
Ability to quickly learn and adapt to new regulatory subject matters and jurisdictions
Proven relationships with key stakeholders, such as those at regulatory agencies and international bodies, legislatures, and central banks
Fluency in English required
fluency in Spanish is strongly desired
Exceptional communication skills, both written and verbal
comfort with public speaking

Job Responsibility

Build and maintain subject matter expertise of the changing regulatory landscape in the areas of digital assets, financial services and capital markets
Advise business units and senior leadership on the development and adaptation of products, business lines and business models in light of existing or anticipated regulatory requirements
Define and execute strategies to proactively influence the development of favorable digital asset regulation in North and South America
Coordinate with the Global Head of Policy on identifying and reacting to significant public policy challenges and opportunities with respect to Ledger’s business priorities
Build strong relationships with other regulatory professionals in the digital asset and traditional finance ecosystems, as well as with relevant governmental authorities and multinational bodies
Lead the development of Ledger’s responses to regulatory proposals, solicitations and consultations
Lead the response of Ledger to regulatory inquiries, examinations or investigations, and contribute to crisis response teams as assigned
Represent Ledger’s perspective on regulatory policy through public speaking and written thought leadership
Assist the Global Head of Policy in managing outside consultants and membership organisations

What we offer

Training: Get trained and gain experience in one of today's most exciting and growing industries
Equity: Employees are the foundation of our success, and we award stock options so you can share in that success as we grow
Medical: Comprehensive health insurance policy offering extensive medical, dental and vision care coverage
Well-being: Personal development, coaching & fitness with our dedicated partners
Vacation: 20 days of paid leave per year
Retirement: 401k with employer match
High tech: Access to high performance office equipment and gadgets, including Apple products
Transport: Ledger reimburses part of your preferred means of transportation
Discounts: Employee discount on all our products

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

New

Senior Regulatory Affairs Consultant - Regulatory Intelligence

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5-7 years of regulatory affairs experience to include previous regulatory intelligence experience
Knowledge of FDA regulations as well as an understanding of the Summary basis of approval and labeling is helpful
A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree preferred
Project management / leadership experience
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work (Quality)
Results orientation
Teamwork and collaboration skills
Consulting skills
Critical thinking and problem-solving skills

Job Responsibility

Regularly search the public domain for new and updated regulations and regulatory guidance documents that can impact the client’s development programs, and report the most critical findings
Regularly search the public domain for competitor product regulatory developments and report the most critical findings
Inform client immediately of any changes to the regulatory environment directly affecting client’s business
Search for non-compliance letters or notices for client’s suppliers and provide a regular report
Perform ad hoc research on specific regulatory topics at client’s request, using the internet and various subscription database tools
Identify public commenting opportunities for draft guidances/regulations and coordinate review and comments from client. Lead the client’s internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities.
Maintain a list of upcoming regulatory meetings/workshops/conferences pertinent to client
Support Regulatory Intelligence activities, including the use of Cortellis, Citeline, WebWatcher. This includes tracking, coordinating and participating in ad hoc searches as well as scheduled activities.

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Director, Regulatory Affairs

Senior Director role in Regulatory Affairs at Beam Therapeutics, a biotechnology...

Location

United States , Cambridge

Salary:

260000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or foreign equivalent, in regulatory affairs
or a closely related field
Five (5) years of progressive, post-baccalaureate experience including: Working in regulatory affairs
Developing regulatory documents and submissions
and Presenting corporate development programs to regulatory agencies
The required five years must also include at least one year of experience (which may have been gained concurrently) involving: Regulatory affairs work within biotechnology specifically, including application of U.S. and global regulatory procedures and practices
Developing regulatory documents and submissions such as IND, CTA/IMPD, BLA, MAA and PIP
and Managing projects in biotechnology regulatory affairs

Job Responsibility

Supporting development and implementation of global regulatory strategy for innovative genetic medicine programs within a fast-paced biotechnology environment
Ensuring integration of regulatory tactics with broader corporate strategy across non-clinical, clinical and commercial development stages
Incorporating evolving United States and global regulatory requirements related to gene editing, gene therapy, rare disease, orphan indications, breakthrough therapies and expedited regulatory pathways
Representing the Regulatory Affairs function on cross-functional and project teams to provide regulatory input throughout development
Developing innovative regulatory approaches, solutions and guidance while mitigating regulatory risks
Collaborating with external stakeholders, including experts, consultants and contracted vendors
Guiding planning, preparation, construction and submission of regulatory documentation
Managing project plans, timelines and prioritization to ensure milestones and goals are achieved
Providing regulatory due diligence support

Fulltime

Senior Manager, Regulatory Affairs

The mission of the Regulatory Affairs group is to implement effective processes ...

Location

United States , St Louis

Salary:

122187.50 - 158125.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
7 years of Regulatory Affairs experience
Minimum of 7 years of US EPA Antimicrobial registration experience
US State Registration experience
Leadership experience managing a team of people
Ability to travel as noted above

Job Responsibility

Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compliance requirements for marketing STERIS products in their assigned areas or regions where STERIS does business
Effectively interface with government agencies, notified bodies, consultants and authorized dealer representatives as necessary to address registration related issues. Act as person responsible for regulatory compliance as assigned by upper management
Provide regulatory guidance and support to project teams and STERIS internal Customers to support new product development and existing product lines in support of registration requirements.
Develop sound global regulatory strategies for new products. Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department’s business partners from the start of product development through qualification testing and submission/registration, and as changes occur or new requirements are identified.
Gather information and documentation on new or modified products to determine submission requirements for particular markets.
Compile and create document registration packages through analysis and synthesis in a standardized format to support product claims and satisfy regulatory authorities.
Critically assess the strength and completeness of documentation created by others
advise improvements to comply with current requirements for particular regulatory authorities.
See that all direct team members maintain submission documents and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
Report to management concerning current, pending, and re-registration approvals. Identify and take action on any unexpected delays

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

Regulatory Affairs Consultant

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics
Strategic and proactive mindset with strong operational execution
Excellent analytical, problem-solving, and negotiation skills
Effective communicator with strong interpersonal, presentation, and leadership abilities
Ability to manage multiple projects independently in a matrixed, multicultural environment
Proficiency in Microsoft Office Suite and regulatory systems
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred

Job Responsibility

Provide regulatory strategy input for small molecule and biologic products
Support regulatory leads in developing contingency plans for CMC-related scenarios
Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
Partner with manufacturing, quality, and external organizations to address CMC-related issues
Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
Support planning and execution of Health Authority meetings, including mock sessions
Identify and implement process improvements to enhance regulatory efficiency and readiness
Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Fulltime

Senior Manager, Government & Regulatory Affairs

GEICO is seeking an accomplished government relations professional to join our t...

Location

United States , Sacramento

Salary:

158875.00 - 248050.00 USD / Year

Geico

Expiration Date

Until further notice

Requirements

Juris Doctor (JD) degree from an accredited law school and admission to practice law in at least one U.S. jurisdiction highly preferred
Minimum 10 years’ relevant government affairs experience with knowledge of insurance regulation, regulatory law, or related public policy fields, preferably within property and casualty insurance
knowledge of auto insurance a plus
Proven experience, with a track record of successfully developing and implementing regulatory and legislative strategies
Deep knowledge of U.S. insurance regulatory systems, including state insurance departments and the National Association of Insurance Commissioners
Strong analytical skills, with the ability to translate complex regulatory developments into actionable business strategies
Strong verbal and written communication and presentation skills tailored to different audiences
Exceptional communication, negotiation, and interpersonal skills, with a collaborative approach to working within cross-functional teams
Ability to balance independent legal judgment with teamwork and enterprise-wide policy development processes
Ability to articulate GEICO’s positions in an impactful and persuasive manner to decision makers and industry leaders and to offer strategic advice on complex legislative and regulatory issues to business professionals

Job Responsibility

Policymaker Engagement: Build and maintain a strong network of key policymakers, including state legislators, heads of relevant executive agencies and their staff, industry members, policymakers (NAIC and NCOIL), and trade associations to efficiently and effectively advocate GEICO’s positions in assigned states. Develop comprehensive strategic plans to facilitate effective engagement with legislative and regulatory stakeholders to achieve GEICO’s business objectives
Regulatory & Legislative Analysis: Review and evaluate impactful insurance regulatory/ legislative proposals, working in close collaboration with relevant Government & Regulatory Affairs colleagues and other internal stakeholders. Ensure that GEICO's business units and corporate functions remain informed about critical and emerging issues
Strategic Monitoring & Reporting: Proactively identify evolving regulatory and legislative trends and effectively communicate relevant insights and potential risks to the Government & Regulatory Affairs team, business units, and senior management to support informed, enterprise-wide strategic decision-making
Strategic Support: Work with the Director of Public Policy and business stakeholders to develop policy positions, strategy, responses/draft language
prepare for legislative and regulatory interactions
and support company’s strategic initiatives
Coalition Building: Support the strategic implementation of GEICO’s key public priorities through coalition building and coordination of external resources. Maximize outside firms and association memberships to successfully advocate GEICO’s priorities. Develop and execute effective and efficient political contributions strategies in assigned states, in consultation with business, to enhance GEICO’s policy agenda
Additional Duties: Assume other regulatory or legislative responsibilities as priorities evolve

What we offer

Comprehensive Total Rewards program that offers personalized coverage tailor-made for you and your family’s overall well-being
Financial benefits including market-competitive compensation
a 401K savings plan vested from day one that offers a 6% match
performance and recognition-based incentives
and tuition assistance
Access to additional benefits like mental healthcare as well as fertility and adoption assistance
Supports flexibility- We provide workplace flexibility as well as our GEICO Flex program, which offers the ability to work from anywhere in the US for up to four weeks per year

Fulltime

Senior Regulatory Affairs Consultant

Product Life Group

Location:
United States

Category:
Consulting

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 16, 2026

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