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Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs
Azienda:

Vertex Pharmaceuticals



Funzione Lavorativa:

Altro

Dettagli della offerta

Job Description: Senior Manager Regulatory Affairs POSITION SUMMARY: The Regulatory Affairs (RA) Senior Manager (SM) participates in the development and implementation of regulatory strategy for an established cystic fibrosis product This individual will be responsible for planning and coordinating complex regulatory submissions, e.g., new therapeutic indications, in the EU as well as supporting affiliates with submissions in the UK and Switzerland. This individual will also represent RA on cross-functional teams. KEY RESPONSIBILITIES: Regulatory Act as the EU Regulatory Lead (RRL) for an established cystic fibrosis product as well as supporting affiliates with submissions in the UK and Switzerland. In collaboration with Global Regulatory Lead (GRL), develop regulatory strategy for assigned projects Ensure projects are appropriately prioritised and progressed in accordance with agreed regulatory plans, including identifying risks from emerging data, changing internal objectives or external threats and communicating to RA Senior Management in a timely manner Manage the preparation and submission of technically complex regulatory submissions, with some supervision, for assigned products in line with regional regulatory requirements Provide appropriate strategic regulatory advice to Submission and Project Teams in a timely manner Keep regulatory affairs senior management informed on the status of global strategies and tactics, procedures and practices, with a focus on regulatory and policy trends in the EU Act as primary Company contact with EU Regulatory Authorities for assigned product(s) Maintain knowledge of regulatory requirements and anticipate, assess and communicate changes in regulatory information to Project Teams and senior management in a timely manner Lead/Participate in local and/or global company process improvement initiatives Ensure all work is compliant with regulatory requirements and company policies and procedures General Work with cross-department teams (e.g. Global Regulatory Subteams) and other key functions to achieve corporate and departmental goals and objectives. Ability to travel to corporate headquarters as well as attend EU meetings as required Exhibit ownership and accountability for projects and internal assignments Ability to plan, schedule and arrange own work activities with appropriate direction from line manager Exemplify Vertex’s core values in fulfilling these job duties Education: Bachelor’s degree in life sciences required SKILLS & EXPERIENCE: Regulatory Recent direct experience of clinical development is essential Leading direct interactions with a variety of stakeholders including EMA and/or national Competent Authorities on clinical development or regulatory submissions Experience of complex regulatory submissions such as MAAs, new indications, and PIPs, and leading other regulatory submissions, e.g. Orphan applications, renewals and CTA applications Good knowledge of regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends General Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct Strategic ability, as evidenced by an awareness of the positioning of local strategy relative to global and international requirements Ability to navigate and be successful in a fast-paced environment while delivering high quality results Adaptable to changing plans when situations require it and able to maintain composure Able to behave independently with minimal guidance where needed, but must understand and embrace being part of a team and working collaboratively with others within the function and cross-functionally Good interpersonal skills and ability to deal effectively with a variety of personalities Acts to promote an energizing, inclusive environment and good morale Fluent written and spoken English EXPERTISE Business and Management Expertise Experience in regulatory affairs with track record of success for complex regulatory submissions Experience across the product life-cycle (development, post-authorization) Specialized knowledge of regulatory environments and respective stakeholders (e.g., EMA, Swissmedic, MHRA). DELIVERING SOLUTIONS Problem Solving Proactively identify risks and develop potential solutions IMPACT Accountability Ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans LEADERSHIP Strategic Planning Responsible for regulatory submissions, including complex submissions, of key impact to the business (e.g., new therapeutic indications, PIPs etc… ) Anticipate submission activities to permit accurate budgeting and forecasting LI-MB1 Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistancevrtx.com. Full time REQ-11374 About Us Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) – a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney disease. Founded in 1989 in Cambridge, Mass., Vertex’s global headquarters is now located in Boston’s Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including nine consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes. For company updates and to learn more about Vertex’s history of innovation visit www.vrtx.com or follow us on Facebook , Twitter , LinkedIn , YouTube and Instagram . The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work. Suggested Jobs Associate Director, Regulatory Affairs


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Funzione Lavorativa:

Requisiti


Conoscenze:
Senior Manager Regulatory Affairs
Azienda:

Vertex Pharmaceuticals



Funzione Lavorativa:

Altro

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