Posted:
1/5/2026, 12:36:52 AM
Location(s):
Mississauga, Ontario, Canada ⋅ Ontario, Canada
Experience Level(s):
Senior
Field(s):
Business & Strategy
About the role
The Labelling Strategy Director provides regulatory labelling expertise and guidance, typically for more complex drug projects and across a Therapy Area (TA)/Disease Area (DA), to Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET) and cross functional Product Labelling Teams (PLT).
The Labelling Strategy Director responsibilities will be aligned to a TA and/or DA, and this individual will contribute to developing and shaping the strategic direction of the labelling component of the regulatory strategy for complex projects and/or disease areas. This individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products. The individual has a key role in the development of the labelling group by sharing knowledge and mentoring peers, and supports and advises the respective Senior Director Group Manager (SDGM) to ensure appropriate project and resource planning. The Labelling Strategy Director will coach or may serve as a line manager for Labelling members in the group and in conjunction with SDGM will be involved in hiring, training, coaching, and career development of staff.
Ensures that the labelling process is followed through the lifecycle of the product.
Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product and/or the disease area, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.
Leads the PLT in the preparation and maintenance of high quality Core Prescribing Information (CPI), EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
Leads the development of labelling negotiation strategies, anticipating HA perspectives.
Provides labelling expertise to the GRST/GRET/PLT for assigned products and/or across the disease area regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.
Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations.
Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling.
Ensures appropriate communication across Labelling subfunctions.
Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.
Leads the development of target labelling documents and supports other Labelling Strategists in the TA as appropriate.
Assist in the development of labelling policies, procedures and SOPs.
Is a visible, approachable leader and role model within and outside of Labelling teams.
Coach or may lead a team of Labelling members, providing guidance and support to the individuals as required depending on their level of experience to ensure appropriate Labelling support across all allocated projects.
Effectively deputise for the SDGM as required.
Required Experience
University Degree in Science or related discipline
3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labelling
Knowledge of labelling regulations and guidances
Excellent verbal and written communication skills
Keen attention to detail and accuracy
Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
Ability to assimilate clinical and scientific information and present it in a concise manner
Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
Must demonstrate competencies in:
Building Relationships (works well across formal and informal networks)
Negotiation Skills (good listener; able to build a consensus)
Critical Information Seeking (works well across formal and informal networks)
Rational Persuasion (able to distil an issue to its key components and suggest solutions)
Interpersonal Awareness (aware of how actions affect other people)
Desirable Skills
Advanced academic training is highly desirable (PharmD, PhD)
Great People want to Work with us! Find out why:
This is the place to make a meaningful impact – on patients’ lives and your personal growth. It’s both exciting and inspiring, and it’s what keeps us motivated every day.
Ready to make a difference? Apply now!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected] (mailto:[email protected]).
We are using AI as part of the recruitment process
This advertisement relates to a current vacancy.
#LI-Hybrid
Date Posted
05-Jan-2026Closing Date
22-Jan-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Website: https://www.astrazeneca.com/
Headquarter Location: Bangalore, Karnataka, India
Employee Count: 1001-5000
Year Founded: 1999
IPO Status: Public
Industries: Emergency Medicine ⋅ Manufacturing ⋅ Medical ⋅ Oncology ⋅ Pharmaceutical