Bilingual CMC Regulatory Affairs Manager

1 Year ago • 5 Years + • Localization

Job Summary

Job Description

We are seeking a Bilingual CMC Regulatory Affairs Manager for a 12-month contract. This role focuses on executing CMC regulatory activities for new product registrations and lifecycle maintenance, including variations and annual reports for products in the US and Canada. You will prepare CMC sections for registration files, clinical trial applications, and respond to regulatory agency questions. This position involves interacting with global functions and other regulatory affairs subfunctions to ensure high-quality submissions and maintain technical product records. You will also evaluate potential changes for regulatory compliance and effectively communicate technical requirements. The role requires experience in Quality, product development, and manufacturing areas, along with a Bachelor's Degree in a Life Science/Pharmaceutically-related field.
Must have:
  • Bachelor's Degree in Life Science/Pharmaceutically-related science
  • Bilingualism in French and English (written/spoken)
  • 5+ years of experience in Regulatory Affairs
  • Experience in Quality, product development, and manufacturing
  • Preparation of CMC sections for new registration files
  • Interaction with global functions and regulatory affairs subfunctions
Good to have:
  • RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD
  • QP certification
Perks:
  • Competitive compensation
  • Inclusive, diverse, and collaborative culture
  • Fitness centre/gym
  • Bistro/cafeteria onsite
  • Commitment to development and career progression
  • Hybrid work model
  • Career growth and internal advancement opportunities
  • Work environment focused on development and employee well-being

Job Details

Please note: This position can be based out of Mississauga Ontario HQ, or our Manufacturing site in Ville St. Laurent, Quebec.

Please note: Visa sponsorship or relocation will not be offered for this position.

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Advil, Voltaren, Robax, NeoCitran, Buckley’s, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

We encourage applicants with accessibility needs to notify us if they have any accommodation needs during the application and/or interview process. Please visit www.haleon.com/accessibility to learn more about our commitment to accessibility.

Do you want to be part of a growing and dynamic team in Haleon Canada? Are you someone who thrives on navigating complex regulatory landscapes and ensuring product compliance across US and Canadian markets? If so, the CMC Regulatory Affairs Manager role could be just what you’ve been looking for.

Job Purpose:

The purpose of this role is to execute CMC regulatory activities for new products registrations and life-cycle maintenance (including variations, annual reports and annual notifications) for the portfolio of products defined by the US and Canada Business Units.

Why Join Haleon?

  • Competitive compensation
  • Inclusive, diverse, and collaborative culture.
  • Fitness centre/gym, bistro/cafeteria onsite.
  • Commitment to development and career progression.
  • Hybrid model either in a modern office located in Mississauga. Montreal site is steps from Côte-Vertu Metro.
  • Career growth: Haleon promotes internal advancement
  • A work environment focused on development and employee well-being

Key Responsibilities:

This role will provide YOU with the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

  • Preparation of CMC sections of new registration files (medicines, medical devices, cosmetics & foods), briefing books, clinical trials applications/INDs, CMC variations, and responses to Regulatory Agency technical questions.
  • Interacts with colleagues in other global functions (e.g. Technical and Supply Chain) and Regulatory Affairs subfunctions (Category and LOCs) to deliver high-quality CMC sections for dossiers, including documents and materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance.
  • Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
  • Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance, including completion of appropriate internal compliance records (e.g. change controls).
  • Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends.

 

Basic Qualifications: .

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor's Degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
  • Bilingualism Required - Due to the nature of the work tasks, applicants must be bilingual in French and English (written/spoken) to be considered, as in their role the incumbent must work closely with external/internal stakeholders in other provinces/countries that do not speak French.
  • 5 + years’ experience in Regulatory Affairs, preferably within a CPG/Consumer Healthcare/Pharma related industry.
  • Experience and knowledge in Quality, product development and manufacturing areas.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP an asset but not required.

#LI-Onsite

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
 

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.

Similar Jobs

extreme network - Sr. Partner Account Manager

extreme network

Texas, United States (Remote)
3 Months ago
IMC - Marketing and Brand Specialist

IMC

Sydney, New South Wales, Australia (On-Site)
1 Month ago
ISS Stoxx - Lead Software Engineer (C#, .Net, & Python)

ISS Stoxx

Makati City, Metro Manila, Philippines (Hybrid)
3 Months ago
Abridge - Recruiting Coordinator

Abridge

San Francisco, California, United States (Hybrid)
1 Week ago
Nice - Team Lead, IT Tech Support

Nice

Ra'anana, Center District, Israel (Hybrid)
1 Month ago
Marvelous games - Consumer Game Translation Check/Editing

Marvelous games

Tokyo, Japan (On-Site)
1 Week ago
Lilt - Gilit (Iraqi) Arabic-based Medical Translators needed

Lilt

Abu Dhabi, Abu Dhabi, United Arab Emirates (Remote)
1 Month ago
oportun - Bilingual English and Spanish Member Loyalty Representative

oportun

Delano, California, United States (On-Site)
1 Week ago
Side - English to German Translator (Full Time - Remote)

Side

Braga, Braga, Portugal (Remote)
1 Week ago
Toast - Emerging Markets Account Executive, Bilingual Spanish - Inside (West Coast)

Toast

San Francisco, California, United States (On-Site)
1 Month ago

Get notifed when new similar jobs are uploaded

Similar Skill Jobs

Optiv - AI Solution Architect

Optiv

Leawood, Kansas, United States (Remote)
2 Weeks ago
Figma - Director, Sales Operations

Figma

London, England, United Kingdom (On-Site)
1 Week ago
sports interactive - Advanced Software Engineer (Graphics)

sports interactive

London, England, United Kingdom (Remote)
1 Week ago
SHL - Product Manager

SHL

Gurugram, Haryana, India (On-Site)
9 Months ago
Tide - Lead Product Manager - Card Payments

Tide

Lithuania (Hybrid)
1 Month ago
Square - Senior Project Manager - Construction

Square

Manchester, England, United Kingdom (On-Site)
2 Weeks ago
OKX - Team Lead, Customer Due Diligence

OKX

Kuala Lumpur, Federal Territory Of Kuala Lumpur, Malaysia (On-Site)
9 Months ago
WildBrain - Product Manager, Finance Systems

WildBrain

Toronto, Ontario, Canada (Hybrid)
3 Weeks ago
Epic Games - Tech Art Lead

Epic Games

Cary, North Carolina, United States (On-Site)
4 Months ago
Tide - Product Design Manager

Tide

Ukraine (Remote)
1 Month ago

Get notifed when new similar jobs are uploaded

Jobs in Mississauga, Ontario, Canada

Open Systems Technologies - MCC Specialist (Maintenance Control Center)

Open Systems Technologies

Montreal, Quebec, Canada (On-Site)
1 Week ago
Tier 9 Game Studios - Game Developer (Role-Playing Gacha Games)

Tier 9 Game Studios

Toronto, Ontario, Canada (On-Site)
2 Months ago
IGG - Gameplay/System Designer

IGG

Vancouver, British Columbia, Canada (On-Site)
4 Months ago
Survay Monkey - Product Marketing Manager II

Survay Monkey

Ottawa, Ontario, Canada (Hybrid)
2 Months ago
Illumina - Director - General Manager, Canada

Illumina

Canada (Remote)
2 Months ago
Scanline VFX - Producer, Visual Pioneering

Scanline VFX

Vancouver, British Columbia, Canada (Hybrid)
4 Months ago
Fortra - Software Engineer III

Fortra

Canada (On-Site)
2 Months ago
Image Engine - Previs Animator

Image Engine

Vancouver, British Columbia, Canada (Hybrid)
2 Months ago
Tactic studios - Senior Graphics Programmer

Tactic studios

Canada (Remote)
3 Months ago
BKOM Studios - Senior Unreal Developer

BKOM Studios

Québec City, Quebec, Canada (Remote)
2 Months ago

Get notifed when new similar jobs are uploaded

Localization Jobs

SBM Management - Bilingual EHS Supervisor

SBM Management

Austin, Texas, United States (On-Site)
4 Weeks ago
2K - Game Localization Specialist (Traditional Chinese)

2K

Shanghai, China (On-Site)
3 Months ago
Shield AI - Senior Software Engineer – Localization and State Estimation (R3123)

Shield AI

San Diego, California, United States (On-Site)
1 Week ago
Wargaming - Localization Specialist/Translator RU-EN (Native English speaker)

Wargaming

Belgrade, Serbia (Hybrid)
1 Month ago
Testronic - Translator - Japanese

Testronic

Japan (Remote)
1 Month ago
GlobalStep - Arabic Localization Video Game Tester (LQA)

GlobalStep

Montreal, Quebec, Canada (On-Site)
1 Month ago
Lilt - Hawaiian Linguist

Lilt

Honolulu, Hawaii, United States (Remote)
1 Month ago
Nintendo - Sr Product Experience Analyst (Bilingual Japanese)

Nintendo

Redmond, Washington, United States (Hybrid)
8 Months ago
Wargaming - Localization QA Specialist, Simplified Chinese

Wargaming

Singapore (On-Site)
1 Month ago
Testronic - LQA Game Tester with Hindi

Testronic

Poland (Remote)
1 Month ago

Get notifed when new similar jobs are uploaded

About The Company

Hello. We’re Haleon. A new world-leadingconsumer healthcarecompany. Shaped by all of us. Together, we’re improving everyday health for millions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol,Advil, Voltaren,Theraflu, Otrivin,and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re building together. In anenvironment thatwe’re co-creating. And a culture that’s uniquely ours. Care to join us.

Bengaluru, Karnataka, India (On-Site)

Karachi, Sindh, Pakistan (Hybrid)

Shanghai, China (On-Site)

Bengaluru, Karnataka, India (On-Site)

Harbin, Heilongjiang, China (On-Site)

Perth, Western Australia, Australia (On-Site)

China (On-Site)

New York, United States (On-Site)

Munich, Bavaria, Germany (On-Site)

View All Jobs

Get notified when new jobs are added by Haleon

Level Up Your Career in Game Development!

Transform Your Passion into Profession with Our Comprehensive Courses for Aspiring Game Developers.

Job Common Plug