Regulatory Affairs Director
AstraZeneca / Apotekarjobb / Göteborg
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The Global Regulatory Affairs Therapeutic area team is a strategic function and plays a key role within the Global Product Teams who work cross functionally to gather expertise and knowledge that informs our drug development programs. They are ultimately responsible for ensuring the pieces fit together to deliver for patients and physicians and provide therapy area regulatory expertise that supports regulatory interactions across the globe to secure fast submissions for our medicines in development.
Description:
The Regulatory Affairs Director (RAD) is accountable for the development and implementation of the regulatory strategy for a product/group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The RA Director possesses strategic leadership skills, has an understanding of regional (US or EU) and/or global regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or Global Product Teams, Investigational Product Teams and relevant stakeholders. Has the ability to take on the Global Regulatory Lead role for a product/group of products.
Core Accountabilities/Responsibilities:
* Leads the development and implementation of innovative global strategies of increasing complexity to maximize the likelihood of regulatory success.
* Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk analysis and mitigation measures.
* Leads the planning and construction of the global dossier and core prescribing information
* Accountable for product maintenance and compliance activities associated with marketed brands.
* Serves as the single point of contact and Global Regulator Affairs (GRA) representative on Product Development Teams (PDT)/Global Product Teams (GPT).
* Leads the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, Reg CMC as well as delivery & enablement.
* Partner with marketing company and regional regulatory affairs staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.
* Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise Global Product Teams (GPT) accordingly.
* Capability to lead key cross-department or cross-functional projects on behalf of Global Regulatory Affairs (GRA) when necessary.
* Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
* Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
* Provide a regional focus and interact with commercial to understand business needs and to ensure regional commercial engagement with the proposed regulatory strategies
Requirements -Education and Experience
* Advanced degree in a science related field and/or other appropriate knowledge/experience.
* Must have previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).
* Significant experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more relevant therapeutic areas. In this case, any previous experience in vaccines/infectious disease is also useful.
* Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
* Experience in relevant therapy area (small molecules & biologics) is preferred.
* Proven leadership and program management experience.
* Ability to think strategically and critically evaluate risks to regulatory activities.
* Ability to work strategically within a complex, business critical and high profile development program.
* Successful contribution to a major regulatory approval at a global level.
* A scientific and clinical understanding of the regulatory sciences.
* Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
If you are interested, apply now!
Welcome with your application no later than February 1st , 2019.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-01-04ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-01-23
Ange följande referens när du ansöker: R-042047
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
jessica.tangefjord@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparredsleden 1
Jobbnummer 4537784
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