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

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 Associate

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

Location

Peru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 5+ years of professional experience in clinical trial regulatory affairs
Proven experience preparing and submitting clinical trial dossiers to the Ministry of Health (MOH) in Peru, including review of Annex 05 and completion of Annex 33
Demonstrated experience preparing and submitting clinical trial dossiers in other LATAM countries
Proficiency with Veeva Vault or similar document management system
Advanced written and spoken English proficiency
Strong regulatory strategy expertise in Peru and LATAM countries
Excellent verbal communication skills for presenting complex regulatory strategies to international clients
Client-focused approach with ability to understand and anticipate sponsor needs
Strong critical thinking and problem-solving abilities
Exceptional interpersonal and intercultural communication skills

Job Responsibility

Act as Local Regulatory Contact (LRC) and prepare and submit clinical trials through the REPEC Platform in Peru
Allocate 50% of daily time as Global Regulatory Lead for assigned global projects, providing strategic oversight and coordination
Prepare country-specific labels and review LATAM labels for regulatory compliance and consistency
Deliver verbal and written regulatory strategy communications to global sponsors, tailoring recommendations to country-specific requirements
Maintain and update the Trial Master File (TMF) in Veeva Vault with study documents and critical milestone dates
Keep project management tools current, including budget tracking and quality issue (QI) tools

Fulltime

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

Regulatory Affairs Specialist

Regulatory Affairs - office based - Bogota. ICON plc is a world-leading healthca...

Location

Colombia , Bogota

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in Pharmaceutical Chemist or next to graduate required
Minimum 1 year of experience in regulatory area within the pharmaceutical or biotechnology industry
Knowledge or awareness of current regional guidelines and regulations is preferred
Technical knowledge in the preparation of a dossier is desirable
Prior experience using computerized information systems required: PC Windows, word processing and electronic spreadsheets
Advanced English level

Job Responsibility

Manage activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), and any other central authorities for the assigned country/ countries
Perform submission and maintenance of new health records, renovations and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws and current local health legislation in accordance with the corporate guidelines and policies, procedures and premises
Review of promotional materials for products for human use of their therapeutic line(s) in Veeva Vault or current tool
Perform submission and monitoring of products for human use of their therapeutic line(s) in procedures such as: PSUR, DSUR, RMPs, and safety information according to current Colombian regulations
Back-up to the Head of Regulatory Affairs and analysts of records in the procedures of INVIMA in order to guarantee the operation of the area
Ensure that IP labels are in adherence to country requirements and submitted where applicable
Support the senior level regulatory staff/country consultant in the maintenance of accurate, up-to date Country Knowledge repositor
Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up-to-date and communicate new information or changes to the Regulatory Intelligence Consultant team
Preparation of electronic regulatory submission of post-registration requests, HMPs, Labeling notifications, additions, publication corrections and database corrections, among other petitions to be field at MoH
Follow-up on the status of the regulatory submissions (paper dossiers) from dispatch to the receipt of proof of protocol

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

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

Head of Japan Regulatory Strategy for Oncology and Rare Disease

Facilitate patient access to Amgen products in Japan through executing on our fi...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 11 years of directly related experience including 6+ years of experience in Regulatory Affairs
OR Master’s degree and 13 years of directly related experience including 8+ years of experience in Regulatory Affairs
OR Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience working with PMDA/MHLW, CROs, and/or contractors
Ability to lead teams
Strong communication skills - both oral and written in Japanese and in English (TOEIC score ≥860 desirable)
Ability to understand and communicate scientific/clinical information
Understanding of regulatory activities and how they affect projects and processes
Ability to set organizational direction & champion change and continuous improvement

Job Responsibility

Provides local input to developing and executing regulatory strategies and effective key regulatory agency interactions
Ensures local labels are developed and maintained in line with local legislation and Amgen standards and procedures
Supervisory oversight for multiple regulatory staff
Be a key point of contact for Japan Regulatory
Senior contact point for regulatory advice for commercial and medical projects for Japan
Translates global and international business plans to local regulatory
Represents Regulatory on Japan affiliate
Contributes to and execute filing plan for Japan
Develops local expertise to evaluate and achieve regulatory success based on proposed strategies
Supports the monitoring, auditing and self-assessment activities under the compliance framework

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

Select Country

Senior Regulatory Affairs Consultant - Labelling

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?