Associate Director – Labelling Strategy
| Company | AstraZeneca |
|---|---|
| Location | Mississauga, ON, Canada |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- 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)
Responsibilities
- Ensure the labelling process is adhered to throughout the product lifecycle.
- Perform all tasks in compliance with established procedures, regulatory requirements, and GxPs.
- Lead the development of labelling strategies aligned with the overall regulatory strategy, interpreting regulations and competitor analyses.
- Guide the preparation and maintenance of high-quality Core Prescribing Information, EU QRD, US PI, and IFUs through to Senior Leader approval.
- Develop labelling negotiation strategies, anticipating Health Authority perspectives.
- Provide labelling expertise regarding language, placement, and regulatory content detail for CPI and MPI.
- Offer clarity on labelling requirements in complex situations, including risk insight and proposing mitigations.
- Evaluate and communicate global regulations and trends on labelling and their business impact.
- Ensure effective communication across Labelling subfunctions.
- Justify and communicate labelling rationale to Senior Leaders for effective decision-making.
- Lead the development of target labelling documents as needed.
- Assist in developing labelling policies, procedures, and SOPs.
Preferred Qualifications
- Experience in Labelling development and/or maintenance
- Knowledge of major markets Labelling regulations
- Advanced academic training is highly desirable (PharmD, PhD)