Regulatory Affairs Manager

GSK Group of Companies

$100K — $120K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Minimum of 8 years in Regulatory Affairs, ideally in pharma/consumer health
  • Post-secondary degree in Life Sciences, Pharmacy, or related field
  • Proven expertise in regulatory interpretations and applications
  • Ability to effectively interact with diverse stakeholders
  • Skilled at managing multiple complex projects independently and collaboratively

Responsibilities

  • Represent Regulatory Affairs on projects, advising on regulations and strategies
  • Collaborate with global and local teams to meet project objectives
  • Prepare and submit regulatory submissions while addressing Health Authority inquiries
  • Engage with regulatory authorities to seek guidance and expedite approvals
  • Support end-to-end product compliance and proper claim development
  • Identify regulatory risks and propose solutions
  • Review formulations and labeling for regulatory acceptability

Benefits

  • Work in a fast-paced, dynamic environment
  • Collaborate with cross-functional teams
  • Opportunity for professional growth in regulatory affairs
  • Engage closely with regulatory authorities
  • Contribute to impactful consumer health product strategies
Full Job Description
This Job Posting is for an existing vacancy.

Work Authorization: Candidates must be legally authorized to work in Canada at the time of application and throughout employment. Visa sponsorship is not available for this role.

Relocation: No relocation assistance is available. Candidates are expected to reside within commuting distance of the position location, or relocate at their own expense.

Salary Range: The base salary compensation range for this position is $ 100,000 - $ 120,000, plus bonus and benefits.

Are you interested in a fast-paced regulatory affairs role that allows you to guide regulatory strategy, partner closely with cross-functional stakeholders, and engage with regulatory authorities to support timely approvals? If so, this Regulatory Affairs Manager position could be an ideal opportunity to explore.

Job Purpose:

As a Regulatory Affairs Manager you will manage end-to-end regulatory activities for the assigned portfolio, shaping practical regulatory strategies that support business and consumer needs while partnering closely with internal and external stakeholders.

Key Responsibilities:

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

Day to day you will:
  • Represent Regulatory Affairs on assigned projects, providing guidance on regulations and developing regulatory strategies. This includes review of formulas for local acceptability and claims development.
  • Collaborate with Global and local stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy and achieve agreed upon standards to maximize overall project delivery time and probability of success (POS).
  • Prepare and submit high quality regulatory submissions for Health Authority and respond effectively to Health Authority queries.
  • Participate in interactions (meetings, teleconferences) with regulatory authorities in order to seek guidance, expedite approval of pending applications.


Stewardship:
  • Support end-to-end regulatory compliance of products in remit.
  • Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
  • Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility on the business.
  • Review labelling and formulations for acceptability.
  • Maintain high level of knowledge on the science of products within defined portfolio.
  • Monitor regulatory trends that could impact portfolio.


Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Minimum of 8 years of progressive experience in Regulatory Affairs within the pharmaceutical/consumer health industry.
  • Post-secondary degree or equivalent in Life Sciences, Pharmacy or related scientific field.
  • Demonstrated expertise in interpreting and applying regulations and guidelines.
  • Demonstrated ability to interface effectively with internal and external stakeholders (other commercial and technical staff, local senior management, external regulators).
  • High ability to manage multiple complex projects and work effectively independently and as part of a cross-functional team.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • 5 years of experience in OTC or Consumer Health.
  • Knowledge of submission requirements and timelines related to drugs and natural health products including NDSs, SNDSs, DINAs, PLAs.
  • Post-graduate Regulatory Affairs Certificate/Diploma, RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD.
  • Proficiency with regulatory systems and tools (e.g. Veeva RIM, eCTD).


AI Statement:

At Haleon, we are committed to a fair, transparent, and human-centered hiring process.

We do not make automated hiring decisions or automated candidate dispositions within our Talent Acquisition systems. All decisions regarding whether to advance a candidate in the hiring process are made by human recruiters and hiring managers.

While we utilize AI tools to assist in ranking candidate profiles based on their experience and alignment with job requisitions, these tools are used solely to support our teams in reviewing applications more efficiently. A human always reviews this data and makes the final decision on candidate progression.

#LI-Hybrid

Job Posting End Date

2026-07-11

Similar Jobs

More Jobs at GSK Group of Companies

More Pharmaceuticals & Biotech Jobs

Find similar Regulatory Affairs Manager jobs: