Senior Director, Global Regulatory Affairs Oncology
Site Name: Collegeville TSA, USA - Massachusetts - Waltham, USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Aug 21 2021 Job purpose: Ensure the development of appropriate global and/or regional regulatory strategy(ies) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicine Profile. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data. Position may have direct reports. General information: Primary locations: US i.e. GSK East Coast sites (you will mainly work on EST time) Asset/product: Blenrep (multiple myeloma) Role reports to: Victoria, Senior Director and Team Leader, Global Regulatory Affairs Direct reports / people management : no Key responsibilities: Accountable to GRL (if regional role) and/or Global Regulatory TA Head for development of appropriate regional or global regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with regulatory agency (ies). Work with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with the global commercial team and local regulatory team to secure best possible labelling commensurate with the available data Lead interactions with local / regional /global regulatory authorities. In performing the role, the job holder will be responsible for: To proactively develop a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit advancement of a given program. Implementation of the global and/or regional strategy(s) in support of the project Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset. Lead regulatory interactions and the regulatory review processes in global/local region Ensuring appropriate interaction with global/regional regulatory counterparts and global commercial teams Ensuring compliance with global/regional requirements at all stages of product life Able to advocate persuasively to senior leaders in GSK and in Health Authorities Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input). Able to effectively lead the Regulatory Matrix Team Capable of providing critical regulatory assessment as part of due diligency/business development activities Why you? Basic Qualifications: We are looking for professionals with the following required skills to achieve our goals (must-have): Bachelor degree or preferably PhD in Biological or Healthcare Science Proven RA and Oncology experience (absolute must) Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence Proven experience of leading global/regional development, submission and approval activities in global/local region(s) including track record of organising and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing requirements in all key markets in the region and sound knowledge globally. Ideally, proven experience of leading regulatory activities outside local region. Extensive Oncology knowledge and proven track record of being able to develop product Significant external network established at least into other pharmaceutical companies and recognised internally and externally as an expert broadly, or in specific areas, of regulatory affairs Preferred Qualifications: The following characteristics are assets (nice-to-have): Experience in Experience with RA filings Soft skills - Proven ability to: Set direction and inspire Communicate, impact, influence and negotiate Think strategically *LI-GSK Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritization, execution, delivering performance. Setting strategic direction and leading on-going organizational transformation. Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit. Managing P&L and capital allocation. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.