Regulatory Affairs Associate - Advertising & Promotional Labeling Job at Parexel (Remote)

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Global Labeling Operations Senior Regulatory Affairs Associate

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

Location

Mexico , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field
advanced degree (MSc, PhD, PharmD) preferred
Fluency in English (verbal and written)
additional languages a plus
Minimum 3 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations
Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management
Experience with flu campaigns, pandemic products, and direct-to-consumer advertising
Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems
Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS
Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing

Job Responsibility

Manager internal global labeling and drug safety activities and coordinate bi-weekly updates
Coordinate readability testing (planning, team review, and communications)
Oversee translations for foundational markets (EU, CH, DE)
Coordinate and upload CH labels to AIPS
submit approved labels to external platforms (HA, ePIL)
Upload approved labels to internal systems (Documentum, Weblabel, intranet)
Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders
Perform data entry in Trackwise/Veeva and prepare annual labeling reports
Review and update submission content plans
prepare change control documentation for CCDS-driven changes

What we offer

Competitive compensation, benefits, and opportunities for career growth
Flexible work arrangements
Supportive and inclusive environment
Opportunities for career growth
Diverse and global client exposure
Learn from experts

Regulatory Affairs Specialist

This position will be working in the BD Interventional Surgery Business Unit on ...

Location

United States , Warwick

Salary:

Not provided

BD

Expiration Date

Until further notice

Requirements

B.A. or B.S. degree in a technical field preferred (e.g., engineering, biology, chemistry, health science). B.A. or B.S. in other field acceptable with appropriate level of experience
Minimum 1-2 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies
Proven ability to resolve problems and to make appropriate regulatory decisions
Good oral and written communications skills - analytical thinking and technical writing
ability to work on cross-functional teams
ability to manage several parallel deliverables
Proficient in using Microsoft Word, Excel, PowerPoint, and Project
Strong communication and project management skills
Must be able to handle multiple tasks with attention to detail with limited supervision
Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills

Job Responsibility

Assess necessity for reporting changes to FDA/Notified Body for proposed device modifications. Prepare robust reporting justifications for changes that do not require supplements or notices. Sends out notifications of change to Notified Body as required
Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders
Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards
Maintains regulatory databases/systems for key regulatory data
Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential product or process impacts
Provides regulatory support during internal/external audits and inspections
Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register devices worldwide
Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance
Carry out the above tasks with minimal supervision

Fulltime

New

Seasonal team member

Longleat is seeking enthusiastic and customer focused Seasonal Team Members to j...

Location

United Kingdom , Longleat

Salary:

10.30 - 12.21 GBP / Hour

Longleat Enterprises Limited

Expiration Date

March 08, 2026

Requirements

A passion for delivering a great guest experience and willing to go out of your way to do so
Good team player with excellent interpersonal skills
Ability to remain calm and efficient under pressure
Excellent communication skills with a confident and friendly nature
Be honest, reliable and committed, and enjoy responsibility and exceeding expectations
You must be aged 16 or over, and above school leaving age to apply for this role
For Attractions Team Member role: applicants must be aged 18 or over
For Guest Experience Team Member role: Experience in a customer service environment is required

Job Responsibility

Food and Beverage Team Member: Delivering outstanding service at varied food outlets
Attractions Team Member: Supporting animal team with giraffe feeding, marshalling seasonal events, ensuring guest safety on rides
Retail Team Member: Engaging with guests, helping pick souvenirs, serving on till
Cleansing Team Member: Ensuring the park remains clean and presentable, focusing on guest toilet blocks
Ranger: Providing a clean and presentable environment, waste disposal, traffic management
Guest Experience Team Member: Welcoming guests at arrivals booths, resolving enquiries, meeting VIP guests, responding to questions via email, social media, or telephone

What we offer

29 days holiday inclusive of bank holidays, rising to 31 days at 5 years’ service
Unlimited free entry to Longleat for our employees
Complimentary tickets to Longleat and Cheddar Gorge and Caves, 18 per annum pro rata
50% off Membership for Friends and Family
Discounts on food and beverages and retail merchandise
Discounts on VIP Experiences and Accommodation
Discretionary bonus scheme
Employee Assistance Programme
Employer contributory pension scheme
Life assurance scheme

Fulltime

New

Planermill Supervisor

You are a natural leader with the proven ability to adapt and remain flexible in...

Location

United States , El Dorado

Salary:

Not provided

Canfor

Expiration Date

Until further notice

Requirements

Minimum 3-5 years of supervisory experience in an industrial environment
Working knowledge of web-based computer applications and Microsoft Office
Grade 12 or equivalent
Valid driver's license

Job Responsibility

Maintain the highest safety standards, ensuring compliance with all policies, procedures, practices, and OSHA regulations
Address unsafe conditions promptly and proactively
Identify opportunities to improve processes and reduce costs while safely meeting production targets
Coach, train, and support team members to maximize performance
Foster open communication and engage employees for input into work processes and systems
Ensure timely implementation of key corporate and operational initiatives, and assist in equipment troubleshooting
Maintain and monitor production goals
Work with other departments to achieve operational goals

Fulltime

New

Customer Service Representative

As a Customer Service Representative, you will embark in a 12- week training pro...

Location

United States , Mt Sterling

Salary:

17.15 - 25.73 USD / Hour

Dot Foods

Expiration Date

Until further notice

Requirements

High School Diploma
Excellent verbal and written communication skills
Proficient in Microsoft programs such as Office, Word, and Excel
Ability to process a high volume of request (email/phone) at a fast, accurate pace

Job Responsibility

Manage customer questions and requests by providing appropriate solutions, ensuring timely and accurate response and resolution
Act as the liaison between the customer and multiple internal departments, including Replenishment, Pricing, Accounts Receivable, and Transportation
Process customer orders to ensure internal order deadlines are completed on time
Go above and beyond to meet customer needs, including appropriate use of empathy
Work closely with a team to include, outside sales, regional teammates, and internal customers
Applies lean thinking and tools to identify and eliminate waste in all areas of the position

What we offer

Significant advancement opportunities
Potential to work from home after 1 year

Fulltime

New

Seasonal forestry opportunity

Every year, Canfor hires numerous Forestry Field Assistants to join us in term p...

Location

Canada , Prince George

Salary:

47600.00 - 68000.00 / Year

Canfor

Expiration Date

Until further notice

Requirements

Current or past enrollment in a forestry or natural resources management program, and/or forestry work experience
Excellent communication skills and an ability to perform physically demanding fieldwork in a team environment
A valid Class 5 Driver’s License

Job Responsibility

Timber stratification and preliminary feature identification using Lidar data and imagery
Road and cutblock layout
Site level plans and ecosystem data collection
Operational cruising
Field information mapping stream and riparian assessments
Supervision of planting, vegetation management, and site preparation activities to ensure compliance with safety, environmental, and quality standards
Completion of post-harvest prescriptions and regeneration surveys
Updating key Silviculture databases following completion of activities
Conducting both field and office activities which relate to Planning
Conducting field surveys and assessments to support block design and reconnaissance efforts

What we offer

paid leave
health & well-being programs

Fulltime

New

General Assistant

We are delighted to offer an opportunity for a General Assistant to join our tea...

Location

United Kingdom , Cheddar

Salary:

10.30 - 12.21 GBP / Hour

Longleat Enterprises Limited

Expiration Date

March 22, 2026

Requirements

Self-motivated with excellent customer service skills
Experience of providing tours or sharing verbal information to groups of people
Experience of communicating with the general public
Excellent written and verbal communication skills
Able to work outside in all weathers
Knowledge of pre - history, geology, Victorian history
Experience of till operation

Job Responsibility

Provide the highest standard of service to customers in a polite, courteous and helpful manner
Ensure the highest standards of presentation and cleanliness throughout the premises
Have a good knowledge of Cheddar Gorge and Caves, its attractions and history
Provide guided tours and interpretation in the Caves and the Museum including fire lighting and flint knapping
Understand and have the ability deliver food service safety compliance to the requirements of the Longleat food corporate policy
Assist with the rotation of stock, reporting any short dated lines to the retail office
Operate the tills and be responsible for the security and accounting of all moneys handled during transactions in line with the cash handling procedure

What we offer

29 days holiday inclusive of bank holidays, rising to 31 days at 5 years’ service
Unlimited free entry to Longleat and Cheddar Gorge and Caves for our employees
Complimentary tickets to Longleat and Cheddar Gorge and Caves, 18 per annum pro rata
50% off Membership for Friends and Family
Discounts on food and beverages and retail merchandise
Discounts on Longleat VIP Experiences and Accommodation
Discretionary bonus scheme
Employee Assistance Programme
Employer contributory pension scheme
Life assurance scheme

Regulatory Affairs Associate - Advertising & Promotional Labeling

Parexel

Location:
United Kingdom , Remote

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 14, 2026

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