Regulatory Affairs Consultant – Compliance & Process Job at Parexel (Warsaw)

Regulatory Affairs Consultant- Regulatory Partner Responsible

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

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
Partner management experience: proven experience in managing relationships with third-party vendors
Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive

Job Responsibility

Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards
monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implement corrective actions as necessary
develop risk mitigation strategies and implement controls to minimize risks associated with partner activities. Act as point of contact for escalations and issue resolution related to partner activities
Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team
participating in policy activities with industry groups and trade associations
Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs
Keep internal databases up to date with local activity and ensure compliance KPIs are adequately kept on track
Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with Has
Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance

What we offer

Flexible work arrangements

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 Regulatory Affairs Consultant

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

Location

Malaysia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Fluent in local language, English, oral and written
Expert MS Office skills
Excellent organizational, time management and interpersonal skills in a global environment
Ability to work successfully in a complex global matrix organization
Proven ability to work effectively both independently and in a team
The expertise, determination and courage to resolve or escalate issues as appropriate
Subject matter expert in job area typically obtained through advanced education and work experience
Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
Partner management experience: proven experience in managing relationships with third-party vendors
Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive

Job Responsibility

Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards
monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary
develop risk mitigation strategies and implement controls to minimize risks associated with partner activities
Act as point of contact for escalations and issue resolution related to partner activities
Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team
participating in policy activities with industry groups and trade associations
Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs
Keep internal data bases up to date with local activity and ensure compliance KPIs are adequately kept on track
Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with HAs

What we offer

Flexible work arrangements

Fulltime

Regulatory Affairs Consultant - CMC vax/bio (home or office based)

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

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University-level education, preferably in Life Sciences, or equivalent by experience
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Knowledge of vaccines or biological processes - must
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)

Job Responsibility

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
Assess change controls and provide regulatory assessments of quality changes in production and quality control
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions
Identify, escalate, and mitigate risks associated with regulatory procedures and activities

What we offer

Flexible work arrangements

Fulltime

Compliance Consultant – Advertising Compliance

We are seeking candidates with experience in advertising review and/or advertisi...

Location

United States , West Des Moines; Sioux Falls

Salary:

49628.00 - 93052.00 USD / Year

Sammons Financial Group

Expiration Date

Until further notice

Requirements

Bachelor's Degree business or related field preferred or equivalent business experience
3-4 years' relevant compliance, internal audit or other equivalent experience
Working knowledge of life and annuity products, with specific knowledge of insurance company operations
Ability to make sound and proper decisions by applying personal knowledge of guidelines, product information and personal professional judgement in review of assigned materials
Excellent interpersonal and customer service skills
Strong analytical solving skills, including the ability to accumulate, organize, and assimilate large amounts of information
Excellent attention to detail and accuracy
including proofreading skills
Ability to manage multiple tasks simultaneously and manage competing priorities
Ability to work independently and be a team player by demonstrating flexibility, understanding of other positions, providing constructive and relevant input to discussions

Job Responsibility

Receive, review, and research applicable state and federal regulations to ensure all regulatory requirements are incorporated into company policies and practices for both Life and Annuity
Partner with and provide subject matter expertise to Sr. Compliance Consultants, Team Advisor or Manager with the receipt, review, research, investigation of and response/preparation to regulatory agencies and client initiated complaints of small to medium scope as assigned by manager
Assist compliance senior management in all aspects of the compliance function related to developing and implementing policies, procedures and controls
conducting reviews of compliance processes and operations
ensuring implementation of any required corrective actions
managing projects
developing and implementing systems to automate processes and procedures to enhance efficiencies
Develop and maintain good relationships with both internal and external customers by handling tasks in a timely and professional manner
Research and address/resolve Red Flag issues
Communicate and train appropriate employees regarding new laws and regulations for both Life and Annuity

What we offer

Comprehensive health coverage for you and your family, including Medical, Dental, Vision, HSA & FSA options, and term life insurance
Competitive compensation with a performance-based incentive program tied to clear goals and individual and/or company success
Invest in your future with our 100% company-funded Employee Stock Ownership Plan (ESOP), plus automatic enrollment in our 401(k)
Work–life balance that means something
Friday afternoons off year-round, generous paid time off, and paid holidays
Commit to your growth with paid development time, tuition reimbursement, and professional development opportunities across industry, individual, and leadership programs
Make an impact beyond the workplace through volunteer time off, and our company nonprofit matching gift program, supporting the causes that matter most to you
An ownership culture that inspires
join a connected, values-driven workplace where employees take accountability, support one another, and are empowered to do their best work—together shaping our future shared success

Fulltime

Senior Regulatory Affairs Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Degree in Pharmacy preferred
+3 years of experience in pharmaceutical, medical device or health industry
Experience in regulatory affairs or relevant discipline is preferred
Solid understanding of drug development
Good knowledge of National Drug Regulations and Procedures
English Proficiency
Good communication skill for external and internal interaction
Good computer literacy skills, comfortable working with database

Job Responsibility

Achieve timely & successful product registration in accordance with corporate & local strategies
Collect any information on new regulations and guidelines and share it in local RA team
Ensure compliance with company regulatory policies, regulations and procedures
Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-functional team meeting
Manage all regulatory tasks & projects including attaining, maintaining product licenses and operations licenses for assigned portfolio on behalf of company as required by local regulations
Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
Develop local registration plans in alignment with local business and global regulatory strategy
Monitor progress of submission & coordinate timely responses to all questions from health authorities
Be compliant with Corporate Policies, Regulations & Procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures
Management of regulatory submissions to support clinical trial activities

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Regulatory Affairs Specialist

PLG is seeking a motivated and detail‑oriented Regulatory Affairs Specialist to ...

Location

Romania

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Degree in a relevant life science discipline (Pharmacy, Biology, Chemistry, or similar)
Minimum 5 years of relevant Regulatory Affairs experience
Strong experience in Romanian Regulatory Affairs
Proven experience across Product Lifecycle Management, including: New MAAs
Variations
Orphan Drugs
Line extensions
Product Information updates
Artwork review
Experience interacting with Health Authorities

Job Responsibility

Prepare, compile, and submit Marketing Authorisation Applications (MAA), including new MAAs and variations, for Romania and assigned EU countries
Support Orphan Drugs, line extensions, and launch readiness activities
Contribute to registration strategies and timelines in collaboration with PLG project teams and clients
Manage post-approval activities, including: Variations, Renewals, Product Information (SmPC, PIL, Labelling), Artwork review and updates
Ensure compliance with approved documentation throughout the lifecycle of assigned products
Monitor and maintain up-to-date knowledge of national (Romanian) and European regulatory requirements and legislation
Ensure full compliance with Regulatory processes, Assigned country regulations, Client-specific procedures
Ensure readiness for internal and external audits
Effectively manage Non-Conformities (NCs) and CAPAs in a timely manner
Act as a key contact with Health Authorities, ensuring effective and professional communication

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cunesoft

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

Select Country

Regulatory Affairs Consultant – Compliance & Process

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?