Associate Director, Global Labelling Strategy

AstraZeneca • Gaithersburg, MD

2d

About The Position

Are you experienced within Regulatory Affairs and Labelling? Do you have a strong scientific background and are able to assimilate clinical and scientific information and present it in a concise manner? Then, join us at the Respiratory and Immunology (R&I) Regulatory Labelling Strategy team to get involved in shaping global regulatory labelling strategies and support the research, development and commercialisation of our R&I products across the portfolio. AstraZeneca’s pipeline of innovative medicines is consistently growing and within the R&I Regulatory Labelling Strategy team we take innovative labelling approaches to bring these R&I life-changing treatments to those who need it – working across our early and late-stage development pipeline and the business as efficiently as possible. As an industry leading R&I Regulatory function, we’re focused and committed to the development of our products as well as to our people – providing an open and supportive space to explore, learn and develop across all regulatory roles and levels. The Role: We are seeking a new member to join the team in the role of Associate Director, Global Labelling Strategy, the role will be located in Gaithersburg. What You’ll Do: Working in the role as Associate Director, Global Labelling Strategy, you will provide regulatory strategic labelling expertise to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT). This role leads the development/implementation of the labelling strategy and maintenance of Core Product Information (CPI) and United States (US) / European Union (EU) Market Product information (MPI) for assigned marketed or pipeline products in the R&I therapy area. The individual contributes to the development of the labelling group by sharing knowledge and mentoring peers.

Requirements

• Bachelor’s degree in Science or related discipline
• 2 - 4 years of pharmaceutical experience, including regulatory and labelling experience
• Ability to assimilate clinical and scientific information and present it in a concise manner
• Knowledge of labelling regulations and guidance
• Excellent verbal and written communication skills
• Keen attention to detail and accuracy
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
• Must demonstrate competencies in building relationships, negotiation skills, critical information seeking, rational persuasion, interpersonal awareness

Nice To Haves

• Advanced academic training is highly desirable (PharmD, PhD)

Responsibilities

• Lead the development of the labelling strategy, in line with the overall regulatory strategy for the product, 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.
• Lead the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality Review of Documents (QRD), US Prescribing Information (PI), and Instructions for Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
• Lead the development of labelling negotiation strategies, anticipating health authority perspectives.
• Provide labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.
• Provide clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and propose mitigations.
• Evaluate, interpret and communicate global regulations and trends on labelling and any business impact these might have on product labelling.
• Lead the development of Target Product Labelling (TPL) documents
• Assist in the development of labelling documents, policies, procedures and SOPs.
• Ensure 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.

Benefits

• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees