Job title: Associate Regulatory Affairs Director I
Company: AstraZeneca
Job description: JOB TITLE: ASSOCIATE REGULATORY AFFAIRS DIRECTOR I CAREER LEVEL: E Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development Be part of the team where you are empowered to follow the science Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals.. About astrazeneca At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development About the team We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients. About the role Accountabilities/Responsibilities: • 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, 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, 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 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 Global Labelling Group subfunctions • Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making. • Leads the development of target labelling documents as appropriate • Assist in the development of labelling policies, procedures and SOPs Education, Qualifications, Skills and Experience Essential Minimum 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) Desirable Preferred Background: • Experience in Labelling development and/or maintenance • Knowledge of major markets Labelling regulations • Advanced academic training is highly desirable (PharmD, PhD) WHY JOIN US ? We believe there’s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals. Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughout SO, WHAT’S NEXT? Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can. WHERE CAN I FIND OUT MORE? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
Date Posted 27-Oct-2022
Closing Date
AstraZeneca 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.
Expected salary:
Location: Bangalore, Karnataka
Job date: Sat, 29 Oct 2022 02:51:10 GMT
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