Regulatory Affairs Generalist Job at Parexel

Regulatory Strategy & Government Affairs Lead

We're hiring an experienced Regulatory Strategy & Government Affairs lead to wor...

Location

United States

Salary:

Not provided

Stedi

Expiration Date

Until further notice

Requirements

3+ years in health tech, fintech, compliance, government affairs, or a generalist in-house role
Excellent judgment and work ethic
Strong writing
Ability to pick up new subject matter quickly
Knowledge of HIPAA transaction standards, CAQH CORE operating rules, and CMS requirements
Ability to extract key information from complex regulatory documents and translate into business strategy
Thrive in ambiguity and create structure from chaos
Independently design scalable processes from scratch
Business acumen to blend legal rigor with strategic persuasion
Relentless, resourceful, and professional

Job Responsibility

Drive Stedi's regulatory affairs strategy by developing deep subject matter expertise and building relationships with payers, regulators and industry standards bodies
Quarterback compliance workstreams as we expand into new product areas
Own the end-to-end process for identifying, escalating, and resolving payer connectivity issues that implicate HIPAA, CAQH CORE, and/or CMS requirements
Conduct research on healthcare and financial services regulatory questions, monitor relevant legislation and rulemaking activity, and draft comment letters for agency proceedings
Draft outreach citing specific, relevant regulation that compels action, advocate for favorable regulatory interpretations, and maintain excellent relationships with payers
Work directly with world-class external counsel when necessary
Represent Stedi in discussions with payers, clearinghouses, and regulators, influence industry standards and operating rules

Fulltime

Regulatory Affairs Generalist

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

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University Degree in a Scientific or Technical Discipline
A few years of experience in an industry-related environment
Experience in regulatory authority-facing roles
Regulatory Operations (Submission management) experience
Experience using Veeva Vault RIMS - strong plus
Outstanding interpersonal and intercultural communication skills (written and verbal)
Critical thinking and problem-solving abilities
Fluent in English, written and spoken

Job Responsibility

Support global and/or local regulatory teams with comprehensive understanding of regional and global regulatory requirements
Manage post-authorization lifecycle maintenance procedures (variations, renewals, PSURs) for multiple licenses
Coordinate health authority interactions and responses to questions
Prepare and organize local-specific documentation (Module 1) to meet national submission requirements
Maintain up-to-date local national systems according to local legislation
Manage impact assessments for technical changes affecting marketing authorizations
Stay current on regulatory requirements and guidelines to ensure compliance
Support health authority inspections as needed
Provide technical and business consulting services within area of expertise
Complete activities within project scope, timeline, and objectives

What we offer

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

Quality Generalist

The Quality Generalist is a entry level position responsible for supporting vari...

Location

United States , Canton

Salary:

50000.00 - 70000.00 USD / Year

Fagron

Expiration Date

Until further notice

Requirements

College degree (science or engineering related major)
cGMP experience in a pharmaceutical manufacturing company (or similar) preferred
Basic problem-solving skills and use of Microsoft Office tools (Word, Excel, Powerpoint)
Ability to work in a fast-paced environment
Ability to handle a high volume of work and rapidly adapt to changing environment
Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management
Ability to take initiative, including asking for and offering help when needed
performs work independently without being prompted
Strong attention to detail and focus on quality, accuracy, and accountability

Job Responsibility

Develop efficient communication tools across departments to support consistent and priority release of products for patients and support day-to-day maintenance of the system
Support tracking and reporting of quality and operational metrics
Support creating and updating on-the-job trainings for the cGMP training system
Provide support on Lean Six Sigma projects to improve the QC laboratory and QA workflow
Participate in team meetings to assess additional needs of departments
Ensure cGMP documentation associated with work activities is complete
Supporting projects in each team as needed
Perform other related duties as assigned

What we offer

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Fulltime

Sales Development Representative

We are looking for a motivated and results-driven Sales Development Representati...

Location

Denmark , Copenhagen

Salary:

Not provided

Keepit

Expiration Date

Until further notice

Requirements

Fluent in Polish (other CEE languages a plus) and comfortable working in English in an international environment
Strong commercial drive and experience building relationships with senior stakeholders
Background in sales development, inside sales, or another customer-facing role
Confident in outbound prospecting via phone, email, and LinkedIn
Proactive, structured, and target-driven approach to building pipeline
Collaborative, ambitious, and motivated to grow professionally

Job Responsibility

Drive pipeline generation and awareness in the CEE and Finnish market through outbound calls, email, and social media
Identify and book qualified meetings with key decision-makers
Collaborate closely with Sales and Marketing to refine messaging, targeting, and engagement strategies for CEE and Finland
Act as a brand ambassador for Keepit, ensuring a professional and positive first interaction

What we offer

A clear career path with the potential to grow into an Account Executive role
A collaborative, energetic culture where learning and success are celebrated
Access to world-class tools, training, and mentoring
The opportunity to shape Keepit’s growth in the CEE and Finnish market while working from our Copenhagen office

Fulltime

Senior Product Manager

Senior Product Manager at Keepit: own complex Data Protection products, drive st...

Location

Poland , Kraków

Salary:

Not provided

Keepit

Expiration Date

Until further notice

Requirements

4+ years of product management experience, with a proven track record in a B2B SaaS environment
Experience owning complex, data-driven or ML products end-to-end, from discovery and research through release
Understanding of data-driven or ML product lifecycle from problem definition to deployment and monitoring
Experience defining analytics schemas and requirements
Strong ability to contribute to domain-level roadmap strategy and communicate that strategy to senior leadership and stakeholders
Solid experience facilitating agile ceremonies: sprint planning, backlog refinement, sprint review, and retrospectives
Excellent communication and presentation skills, with the ability to tailor messages to different stakeholders
Demonstrated ability to manage senior stakeholders and represent product in leadership and customer engagements
Strong problem-solving skills with a user-first mindset and the ability to anticipate and navigate risks and trade-offs

Job Responsibility

Own the roadmap and strategy for your domain
Drive initiatives that shape your area’s direction
anticipate risks and trade-offs
and ensure what gets built delivers measurable customer and business value
Own backlog refinement and lead core Agile ceremonies
Be the voice of the customer by developing deep expertise in your product area and customer segment
Manage stakeholders and drive alignment across teams
Coordinate cross-team dependencies and communicate clearly with diverse audiences
Use sound frameworks and data to make objective decisions
Use strong communication and team-building skills to rally teams around a shared vision, leading effectively without formal authority

What we offer

Creative tax (KUP 50)
4 additional working days of vacation leave per full calendar year
3 days of internal sick leave without a doctor`s note
Health and Life Insurance
Employee Capital Plan (PPK)
Multisport card compensation
Coverage of professional training sessions, meetups, etc.
English-speaking club with native speakers
Polish language classes
Internet and Glasses reimbursement

Fulltime

Sales Development Representative

We are looking for a dynamic and results-driven Sales Development Representative...

Location

Italy , Milan

Salary:

Not provided

Keepit

Expiration Date

Until further notice

Requirements

Fluent in Italian and comfortable working in English in an international environment
Strong commercial mindset and the ability to build trust with senior stakeholders
Experience in sales development, inside sales, or another customer-facing role
Confident in outbound prospecting via phone, email, and LinkedIn
A proactive, structured approach to building pipeline
Motivated by targets and energized by creating new opportunities
A collaborative team player with the ambition to grow

Job Responsibility

Drive pipeline generation in the Italian market through outbound calling, email outreach, and social media
Create new business opportunities and book qualified meetings with key decision-makers
Work closely with Sales and Marketing to refine messaging, targeting, and outreach strategies for Italy
Act as a brand ambassador for Keepit, ensuring a professional and engaging first interaction

What we offer

Competitive salary
Pension scheme
A modern, energetic global work environment
Regular team-building activities
Opportunities for professional development and career advancement

Fulltime

Enterprise Sales Director - DACH

Keepit is establishing - for the first time - a Sales Director Enterprise (DACH)...

Location

Germany , München

Salary:

Not provided

Keepit

Expiration Date

Until further notice

Requirements

10+ years of enterprise SaaS sales leadership experience
Proven track record of exceeding revenue targets in DACH enterprise markets
Strong background in the Microsoft ecosystem
Deep expertise in: Cybersecurity
Backup & Recovery
Archiving
Compliance
Strategic Sales & Account Management
Experience managing and expanding very large enterprise accounts (25,000+ employees)
Strong track record in land-and-expand models and driving NRR

Job Responsibility

Leadership & Team Development
Build, lead, and scale a high-performing, distributed Enterprise Sales team across DACH
Foster a collaborative, high-accountability leadership culture
Recruit, develop, and retain top enterprise sales talent
Establish excellence in execution, coaching, and performance management
Enterprise Revenue Ownership
Own and deliver the DACH Enterprise revenue target (new business, expansion, and renewals)
Drive Net Revenue Retention (NRR) through structured account growth and retention strategies
Lead complex, multi-year enterprise SaaS deals (€500K–€5M+)
Strategic Account Expansion

Inventory Integrity Executive

A very exciting opportunity has arisen to be part of a newly created, dedicated ...

Location

Romania , Remote

Salary:

Not provided

Arrow Electronics

Expiration Date

Until further notice

Requirements

English language fluency
European language abilities would be an advantage (Italian, French, Spanish distinct advantages)
Happy to travel extensively (>70% time visiting customer locations) within EMEA
Unrestricted right to travel freely within and across EU borders
Previous experience from a logistics/warehouse/inventory control area would be an advantage
Understanding of warehouse storage systems and methodology
Appreciation of SOX controls and how inventory records impact financial statements
Ability to work and think independently
Laser sharp attention to detail and curiosity to get to the root of a problem
Effective verbal and written communication skills

Job Responsibility

Plan an efficient cycle of inventory counts and audits throughout the year at Arrow’s customer locations
Perform robust, efficient and SOX/finance compliant counts of Arrow owned inventory at customer locations and report back results
Participate in post count reconciliation activities, driving towards a compliant, accurate and fully documented result for each location
Provide internal feedback about customer operational handling of Arrow owned inventory and make recommendations
Root cause analysis and corrective actions for inventory discrepancies

What we offer

Permanent contract
Competitive salary and benefits package
Travel expenses fully paid
Company car
Flexibility – remote working, either from home office or an Arrow location of your choice, when not on site with customers

Fulltime

Regulatory Affairs Generalist

Parexel

Location:
United Kingdom

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 09, 2026

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