Senior Regulatory Affairs Consultant - Labelling Job at Parexel (Remote)

Regulatory Affairs Consultant - Labelling

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

Location

Australia , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
8 years + experience in an industry-related environment, inclusive of 2+ years of labeling/regulatory experience combined with other global responsibility from Australia including New Zealand.
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Consulting skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
Previous experience working in industry in support of Global Labeling, Regulatory (Clinical / Safety), or Medical Writing for labelling updates
Use of document management tools (internal systems) and external platforms

Job Responsibility

Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
Completes activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
Facilitates client decision making by framing issues, presenting options and providing objective business advice
Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
Acts as a trusted advisor to clients and/or project team on technical and/or process issues
Supports development of business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
Interacts professionally at multiple levels including senior management within a client organization
Facilitates clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management

What we offer

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

Senior Regulatory- Labelling

Join Our Team as a Regulatory Affairs Labelling Expert! Are you ready to make a ...

Location

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Language Proficiency: Fluent business English (or native English), with additional EU language skills as a plus
Educational Background: A degree in pharmacy, medicine, life sciences, or a bachelor’s degree in science
Regulatory Affairs Expertise: Proven experience in regulatory affairs with a strong track record in labelling activities for innovator drugs on a global level
Lifecycle Management: Experience in handling marketing authorizations and their lifecycle management
Regulatory Knowledge: Sound understanding of pharmaceutical and regulatory requirements in the EU and ideally in one ICH region
Technical Skills: Affinity for databases, labelling software tools, and project management software, with the ability to monitor and adhere to timelines
Personal Attributes: Team player with excellent communication skills, conscientious, accurate, and responsible
Software Proficiency: Confident in using MS Excel, MS Word, databases, and document management systems

Job Responsibility

Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and also for non-EU markets, preferably including development of target product/labelling profiles
Manages creation and maintenance of CCDS/CCSI/RSI, as applicable, in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e.g. from medical, safety department)
Ensures communication to internal / external stakeholders regarding new and updated CCDSs and Product Information
Escalates deviation and compliance issues to the labelling governance bodies (e.g. Safety monitoring committee, Global labelling boards) as necessary
Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level
Planning and expediting the approval projects using the internally available or client-based software tools including databases and document management systems
Providing regulatory expertise to regulatory programs and projects as well as to clients
General guidance (consultancy) of Cencora staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislation
Creation, revision, editing and maintenance of regulatory documentation
Professional interaction with clients and Health Authorities

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

Senior Director, Vaccines Medical Affairs Lead

Provide scientific leadership for the vaccine business in Japan. Develop and exe...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD)
10+ years of Medical Affairs experience in vaccines/infectious diseases, including 7+ years of people leadership
Proven track record in national-level strategy development and execution for new product launches/indication expansions
Experience in scientific dialogue with PMDA, MHLW, municipalities, and academic societies (presentations, chairing, committee participation)
Practical understanding of Pharmaceutical Affairs Law, GCP, GPSP, GVP, Clinical Research Law, Personal Information Protection Law, JPMA Code
Deep expertise in vaccine-related Medical Affairs
Leadership: Inspire, develop, and lead teams in dynamic environments with scientific excellence
Communication and relationship-building skills across internal and external stakeholders
Compliance: Promote appropriate use through understanding of industry regulations
Learning agility: Ability to quickly self-learn necessary medical/scientific knowledge

Job Responsibility

Develop annual Medical Affairs Plans (MAPs) aligned with Japan’s infectious disease epidemiology, NIP (National Immunization Program), local implementation, and decision-making processes
Lead launch preparation and execution for new products, indications, and technologies
Identify unmet medical needs and healthcare disparities via advisory boards
create and drive action plans to address data gaps
Lead unbiased scientific communication, HCP education seminars, data generation initiatives, and development of scientific materials
Contribute to lifecycle planning for both inline and pipeline vaccines
Design Japan Evidence Plans covering epidemiology, outcomes, and implementation science
Utilize databases (JMDC/MDV/NDB) and regional cohorts to visualize effectiveness, safety, and real-world implementation
Oversee publication and conference presentation plans
Support investigator-initiated studies and medical grants per internal policy

Fulltime

Senior Clinical Supplies Project Manager

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

Location

United Kingdom , Reading

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree or equivalent, preferably in a scientific or pharmaceutical discipline
At least three 2-3 years of experience in clinical supplies planning/supply chain management, with (5) years of experience in clinical supplies, clinical research or pharmaceutical development
Working knowledge of the Clinical Trial Supply process
Working knowledge of project team structure and processes
Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
Knowledge of project management and Clinical customer relationship building
Knowledge of the ‘Customers’ team structures and processes
Excellent verbal and written communication skills
Ability to influence others
Ability to multi-tasks

Job Responsibility

Manage clinical supply planning and forecasting for study protocols
Serve as member of clinical study team and/or clinical drug supply team, as assigned
Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy
Support design and set-up of IRT system
Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline
Coordinate the origination, proofing and translation of clinical study labels, as required
Monitor global clinical supply inventory at the clinical site level for both IRT and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly
Coordinate drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs, as required
Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
Serve as ‘consultant’ for managers throughout the organization on issues related to clinical supplies and project management

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

New

Healthcare Assistant & Lead Healthcare Assistant

Are you passionate about supporting older people and making a meaningful differe...

Location

Ireland , Cork

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Experience in elderly care is desirable but not essential (training may be provided)
QQI Level 5 in Healthcare Support or equivalent is an advantage
A caring, patient and respectful approach to supporting older people
Ability to work flexible shifts including days, nights, and weekends
Strong commitment to resident safety, dignity and wellbeing
Applicants must have legal entitlement to work in Ireland

Job Responsibility

Deliver person-centred care to residents with dignity and respect
Support residents with activities of daily living where required
Encourage independence and social engagement
Maintain a clean, safe and comfortable living environment
Build positive relationships with residents, families, and colleagues
Follow all health, safety and safeguarding procedures
Assist with compliance processes, inspections, and quality standards
Lead Healthcare Assistants will also assist in guiding care teams, supporting best practice, and helping maintain high standards of care delivery

What we offer

Flexible working hours to support work–life balance
Local employment opportunities within the Douglas, Cork area
Competitive rates of pay in line with experience and role
Supportive team environment with ongoing training and development
Employee wellbeing initiatives
Uniform provided
Free on-site parking
Meals provided while on duty

New

Bakery Team Member

Join us to "Change Hospitality For Good". Here at the Cornish Bakery, we want to...

Location

United Kingdom , Falmouth

Salary:

8.05 - 12.80 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Eligible to live and work in the UK

Job Responsibility

Make the World’s Best Coffee
Deliver Outstanding Customer Service
Prepare Award Winning Food
Maintain High standards within the Bakery
Be part of a Team who strive to Aim Higher at all times

What we offer

50% discount on food and drink
Pasty Perks – bespoke reward system offering discounts and savings on favourite brands
Financial well-being benefit through Stream – save directly from wages into a high interest savings account or access wages before pay-day
Employer funded health and wellbeing services with access to a 24/7 GP line, Employee Assistance Program and discounted gym memberships
Paid birthday day off
Member of the shareholder fund (service dependent)
Team social events with in-bakery incentives
Up to 28 days of holiday (including bank holidays), pro rata if necessary

New

Housekeeping Assistant

In Glasgow's prestigious West End, Kelvinside Manor provides luxurious accommoda...

Location

United Kingdom , Glasgow

Salary:

12.27 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Experience from a housekeeping or domestic cleaning role
Basic understanding of infection control, COSHH, and compliance standards
Ability to follow instructions and cleaning schedules
Ability to report issues
Ability to work well with others in a professional and courteous manner
Pride in your work, attention to detail, time management, and respectful communication
Ability to work well as part of a team or on your own
Demonstrating a kind and caring nature to all within the care home
Satisfactory references
Disclosure Scotland Scheme Membership (PVG)

Job Responsibility

Maintaining the highest levels of cleanliness in public areas and bedrooms within the home
Responsible for the wash, dry, iron and put away of laundry
Ensuring that our residents' care home facilities, public areas and rooms are maintained to the highest cleaning standards
Replenish and maintain supplies in both resident rooms and common areas
Communicate effectively with residents and colleagues to address needs and concerns

What we offer

Competitive benefits
Overtime rates
Flexible working hours considered

Parttime

Senior Regulatory Affairs Consultant - Labelling

Parexel

Location:
United Kingdom , Remote

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 20, 2026

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