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Senior Regulatory Affairs Business Development Director, Oncology

Местоположение Гейтерсберг, Мэриленд, США Идентификатор вакансии R-091339 Дата публикации 10/07/2020

Within Oncology Regulatory Affairs, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. As an industry leading Oncology Regulatory function, we’re growing fast and we’re as focused and committed to the development of our people as we are our business – providing an open and supportive space to explore, learn, grow and develop across all roles and levels.

The Senior Regulatory Affairs Business Development Director is accountable for leading the strategic regulatory activities for business development aspects related to the review and analysis of a potential product/group of oncology products of various levels of increasing complexity. In addition, this role will contribute to the decision-making process to go or not go into a development agreement or a partnership of similar nature with a third-party.

You will possess strategic leadership skills, have a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs. Experience and knowledge of the Oncology disease area is critical to being able to influence cross-functional discussions within Business Development and relevant stakeholders.

The Senior Regulatory Affairs Business Development Director has the ability to take on the Lead role to analyse from a functional perspective, the opportunity, strengths and weaknesses for a product/group of products intended for acquisition or development partnership, or for the regulatory evaluation of any third party of interest to AstraZeneca within Business development Oncology. You’ll have the ability to deliver the Oncology Regulatory Science and Strategy (ORSS) regulatory assessment as well as serve as the Regulatory Representative on the Business Development Team to present the ORSS assessment and recommendations to Senior Leadership. You will also act as a Business Development Team Member on behalf of ORSS for any on-site activity with a third-party, as well as the transfer of relevant regulatory information if an agreement takes place.

Typical Accountabilities:

Business Development Regulatory Analysis:

  • Accountable for the development of the regulatory review and evaluation of global nature for a product/ group of products of various levels of complexity, and for ensuring that the assessment brings all existing regulatory information into a concise analysis designed to deliver the core necessary information to make a business development decision.
  • Leads the assessment activities, communication and updates of the Regulatory Assessment Document for assigned products/projects deal.  Ensure appropriate cross-functional consultation within the Business Development team.
  • Accountable for the delivery of all relevant regulatory reviews that include available quality, safety, efficacy data, level of interactions with authorities, geographical scope of the deal, the current probability of regulatory success together with risk mitigation measures that would be necessary if the deal was favourably considered by the company. Partner with Reg CMC lead to ensure an aligned regulatory assessment has been made,
  • Lead the objective assessment of emerging data against aspirations as the assessment progresses in the cross-functional team and update senior management on project risks/mitigation activities.

Leadership:

  • Serves as the single point of contact and ORSS subject matter expert representative on Business Development Teams.
  • Leads the planning and construction of the regulatory assessment and core review information.
  • Leads the Global Regulatory Technical  review with taking into account input from key Business Development members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement, as necessary within the scope of the foreseen deal. This includes the need to take into account regional regulatory requirements that will be integrated into an optimum Global Regulatory Assessment that in turn contributes to the Global Business Development Evaluation.
  • Ensure effective regulatory representation in potential partnership activities.
  • Ability to provide a regional focus  in consultation with Regulatory Regional Directors and in addition to be the overall global lead in late stage complex projects. Accountable for interacting with the cross-functional team to ensure business needs are understood and to ensure the aspects of commercial engagement with the proposed regulatory strategies/risks/mitigation plans are clearly identified during the review.
  • Accountable for any follow-up activity.
  • Lead the oncology regulatory staff working on Business Development activities to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
  • Partners with Global Regulatory Business Development Team to ensure technical, operational, and contractual deliverables are met seamlessly.
  • Support skill-development, coaching, and performance feedback of other oncology regulatory staff working within Regulatory Business Development.
  • Provide regulatory leadership as needed in product in-license/due diligence review, partnering, product divestment and product withdrawal.
  • Capability and credibility to lead key complex cross-department or cross-functional projects on behalf of ORSS and ability to cope with ambiguity and manage senior stakeholders, when necessary.
  • Proactively contributes to the across TA RAD community and/or across Oncology objectives and activities.

Regulatory Environment:

  • Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise Business Development Teams accordingly.
  • Has developed and actively uses external relationships with key stakeholders to reinforce AstraZeneca’s regulatory credibility.

Education, Qualifications, Skills and Experience required:

  • 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.).
  • Previous demonstrated experience of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within oncology.
  • 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

Location: Cambridge, UK or Gaithersburg, US

Salary: Competitive + Excellent Benefits

Closing Date:

Next steps, if the role looks suitable to you please apply!



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 authorisation and employment eligibility verification requirements.

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