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

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

Associate Marketing Manager - Access Portfolio

This is where creativity meets strategy. As a member of the Baxter Marketing tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Compelling & Concise Communication
Creative & Innovative Thinking
Strategic Planning
Competitive Intelligence
Collaborative
Digitally Savvy

Job Responsibility

Own and execute global marketing strategy for the Access/Sets portfolio across the full product lifecycle, including NPD, sustaining initiatives, regulatory transitions, cost reduction, and product phase-out
Develop and maintain portfolio roadmaps, prioritization recommendations, and resource needs in alignment with business objectives
Identify unmet customer needs and growth opportunities through market analysis, competitive benchmarking, and customer engagement
Serve as the global marketing member on project core teams for NPD and SPO initiatives, representing the voice of the customer throughout the development process
Define and communicate market and customer requirements, including intended use, value propositions, and usability insights, in partnership with R&D and Marketing Communications
Lead or support market research activities such as customer usability studies, willingness‑to‑pay assessments, qualitative interviews, and quantitative research
Conduct market impact assessments for product changes (i.e., change control) and own assigned marketing deliverables
Develop commercial business cases, in partnership with Finance, to support new product and portfolio initiatives
Support development of global value propositions and pricing strategies informed by customer needs and competitive dynamics
Monitor and benchmark competitive offerings, identifying implications for portfolio strategy and positioning

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Marketing Manager- Access Portfolio

This is where creativity meets strategy. As a member of the Baxter Marketing tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Owns and execute global marketing strategy for the Access/Sets portfolio across the full product lifecycle, including NPD, sustaining initiatives, regulatory transitions, cost reduction, and product phase-out
Develop and maintain portfolio roadmaps, prioritization recommendations, and resource needs in alignment with business objectives
Identify unmet customer needs and growth opportunities through market analysis, competitive benchmarking, and customer engagement
Serve as the global marketing member on project core teams for NPD and SPO initiatives, representing the voice of the customer throughout the development process
Define and communicate market and customer requirements, including intended use, value propositions, and usability insights, in partnership with R&D and Marketing Communications
Lead or support market research activities such as customer usability studies, willingness‑to‑pay assessments, qualitative interviews, and quantitative research
Conduct market impact assessments for product changes (i.e., change control) and own assigned marketing deliverables
Develop commercial business cases, in partnership with Finance, to support new product and portfolio initiatives
Support development of global value propositions and pricing strategies informed by customer needs and competitive dynamics
Monitor and benchmark competitive offerings, identifying implications for portfolio strategy and positioning

Job Responsibility

Driving global marketing strategy and execution across the full product lifecycle for the Access portfolio
Serves as the primary commercial representative for new product development (NPD), sustaining project organization (SPO) initiatives, and in‑market optimization
Working cross‑functionally with R&D, Regulatory Affairs, Medical, Quality, Supply Chain, Finance, and regional marketing teams
Accountable for portfolio strategy, market insights, launch excellence, and commercial performance

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Associate Manager of Marketing - Elastomeric Infusion

This is where creativity meets strategy. As a member of the Baxter Marketing tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Compelling & Concise Communication
Creative & Innovative Thinking
Strategic Planning
Competitive Intelligence
Collaborative
Digitally Savvy

Job Responsibility

Owns and execute global marketing strategy for the elastomeric portfolio across the full product lifecycle, including NPD, sustaining initiatives, regulatory transitions, cost reduction, and product phase-out
Develop and maintain portfolio roadmaps, prioritization recommendations, and resource needs in alignment with business objectives
Identify unmet customer needs and growth opportunities through market analysis, competitive benchmarking, and customer engagement
Serve as the global marketing member on project core teams for NPD and SPO initiatives, representing the voice of the customer throughout the development process
Define and communicate market and customer requirements, including intended use, value propositions, and usability insights, in partnership with R&D and Marketing Communications
Lead or support market research activities such as customer usability studies, willingness‑to‑pay assessments, qualitative interviews, and quantitative research
Conduct market impact assessments for product changes (i.e., change control) and own assigned marketing deliverables
Develop commercial business cases, in partnership with Finance, to support new product and portfolio initiatives
Support development of global value propositions and pricing strategies informed by customer needs and competitive dynamics
Monitor and benchmark competitive offerings, identifying implications for portfolio strategy and positioning

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Senior Associate - Distribution Support

This is a client-facing role that requires you to work closely with colleagues a...

Location

United Kingdom , Leeds

Salary:

Not provided

Waystone Governance Ltd.

Expiration Date

Until further notice

Requirements

Third level, minimum B.A. degree
At least 4 years’ experience working with international clients and with exposure to alternative UCITS and AIFs, ideally within a sales support or regulatory support team for an asset manager or fund service provider
An understanding of the regulatory landscape in the UK & EEA as it relates to distribution is a must
Excellent oral and written communication skills in English
Strong organisational skills, particularly an ability to prioritise multiple tasks concurrently while maintaining attention to detail
Collaboration with colleagues across geographic and functional boundaries
Proactive problem resolution and an ability to independently manage tasks
High levels of personal integrity and client service
An ability to combine an understanding of local markets within the wider business & regulatory context
Self-motivation and confidence

Job Responsibility

Attend client calls during the onboarding phase and conduct regular meetings with clients post-onboarding to ensure service deliverables are being met
Working with clients’ product experts within the regulatory framework to complete jurisdictional analyses of target markets and agree investor types and classification
Working with clients’ product experts within the regulatory framework to formulate investor query responses
Working with internal teams to ensure necessary fund registrations / AIFM passports or pre-marketing permissions are in place prior to carrying out any regulated distribution activity
Agreeing communications with clients for pre-marketing and marketing campaigns and directly issuing to potential investors
Review and approve client marketing materials in line with FCA rules and the EEA's cross-border distribution framework
Providing fund documents (point of sale) and marketing materials to investors
Ensuring all activity is carried out in accordance with the team’s written policies and procedures
Ensure the team’s procedures and processes are maintained to a high standard
Support the Manager in creating new processes / procedures when required

Fulltime

Hr Director

Our Pittsburgh client is seeking an HR Director for a fully on-site, contract-to...

Location

United States , Pittsburgh

Salary:

43.00 - 46.00 USD / Hour

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Human Resources, Business Administration, or a related field, or equivalent experience
7–10+ years of progressive HR experience, including leadership responsibilities
Proven experience leading HR teams and driving strategic initiatives
Strong expertise in employee relations, compliance, and HR best practices
Experience handling sensitive and complex workplace issues
Excellent leadership, communication, and decision-making skills
Proficiency in HRIS systems, ATS platforms, and Microsoft Office
HR certification preferred
Experience in a nonprofit or people services environment is a plus
Background checks and other pre-employment requirements apply

Job Responsibility

Lead and develop the HR team across all functional areas
Oversee and optimize daily HR operations, ensuring efficient and compliant practices
Serve as a strategic partner to executive leadership on workforce planning, retention, and organizational development
Provide guidance on complex employee relations matters, investigations, and performance management
Drive the development and implementation of HR policies, programs, and initiatives
Ensure compliance with federal, state, and local employment laws
Evaluate and improve HR systems, processes, and reporting
Support a positive, inclusive, and high-performing workplace culture

What we offer

Free parking
Medical, vision, dental, and life and disability insurance
401(k) plan

Fulltime

Marketing Manager

We are looking for a versatile Project Manager to lead brand-building efforts an...

Location

United States , Detroit

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Proven experience in marketing management with responsibility for both strategy development and campaign execution
Strong background in print marketing, creative coordination, and production of customer-facing collateral
Demonstrated success in B2B marketing, including brand-building and client engagement activities
Hands-on experience with digital marketing, email campaigns, and campaign planning across multiple channels
Ability to manage several projects at once while maintaining attention to deadlines, budgets, and quality standards
Strong relationship-building and communication skills, with confidence interacting with clients and external partners
Ability to collaborate effectively with cross-functional teams, including sales, design, and production groups

Job Responsibility

Create and implement integrated marketing plans that support brand visibility, customer engagement, and business growth across multiple channels
Work closely with design and production partners to develop compelling printed assets such as brochures, magazines, journals, and related promotional materials
Lead marketing initiatives from initial planning through final delivery, managing schedules, budgets, and quality expectations throughout the project lifecycle
Represent the organization at industry gatherings, networking events, trade shows, and community activities to promote the brand and expand market presence
Cultivate strong relationships with existing clients by identifying their evolving needs, encouraging long-term loyalty, and uncovering opportunities for additional services
Partner with sales stakeholders to align marketing efforts with business development goals and support outreach to prospective customers
Monitor brand presentation across campaigns, collateral, and customer touchpoints to maintain a consistent and strong market identity
Contribute to campaign development in areas such as email outreach, B2B promotions, digital marketing, and brand awareness initiatives

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

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Regulatory Affairs Associate - Advertising & Promotional Labeling

Job Description

Job Responsibility

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