Shire Jobs

Reference #: 408667 Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - North Carolina - Durham Posted Date: Nov 21 2024

Are you interested in a highly-visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios?  If so, this Senior Regulatory Project Manager could be an ideal opportunity to explore. As a Senior Regulatory Project Manager, you will be responsible for global nonclinical regulatory strategy for regulatory submissions and health authority interactions for assigned products. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Drives the Nonclinical strategy,coordinatesthetimelypreparationand authors, as needed,technical (Nonclinical) regulatory documents to support development/registration/lifecycle maintenance submission content,in accordance withthe applicable regulatory& scientific standards,and taking into accountthe evolving regulatory requirements. Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies. Mentors or trains staff. May have direct line management responsibility. Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate.  Provides strategic direction, data assessment and conclusions within and across departments. Able to establishorganizationalnetworks (internal and external understanding departmental constraints/pressure within a highly complexorganization Engages and may lead Nonclinical Subject Matter Expert activities, both internally (for increased compliance,harmonizationand efficiency) and externally(external advocacy and shapingtheregulatory environment). May deliver Nonclinical regulatory strategy to support major audits (e.g., DQA, CQA). Has accountability for submission content. Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development and registration of biopharmaceutical products, to expedite submission, review and approval of global Nonclinical applications. Ensures all appropriate Nonclinical regulatory aspects for clinical trials are in place to avoid clinical holds. Ensures information submitted in clinical/marketing applications/lifecycle maintenance submissions meets regional requirements with minimal unanticipated questions. Formulates novel approaches and influences people, evaluating/improving Nonclinical Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence Nonclinical project and policy issues that are aligned with business needs ensuring optimum position for the company. Operates with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicates sensitive matters or those with potential for high business impact. May participate in corporate evaluation and provide Nonclinical regulatory support/advice to in-licensing and divestment projects.

Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Life Sciences or related discipline. Minimum of three years experience in nonclinical drug development. Minimum of one year experience in complex worldwide Nonclinical regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment. Minimum of one year project management experience.

Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to manage and direct multiple projects/teams Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings Demonstrated ability to handle complex global Nonclinical issues through continuous change and improvement. Demonstrated ability to lead the nonclinical strategy and submissions for oncology complex clinical trials. Developing experience in major filing activities (MAA/NDA/BLA, key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development) Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate internal colleagues and formulate approaches to most effectively meet new requirements. Identified as Nonclinical Regulatory expert in a specific subject area. Highly developed interpersonal, presentation and communication skills with established internal and external networks. Proven experience in supervising and training junior staff within an organization and has the ability to motivate and lead others.

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 Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. The annual base salary for new hires in this position ranges from $128,350 to $173,650 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK? Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stro