Director Of Regulatory Affairs Eu Ptc Therapeutics
Há 3 dias
About the jobJob Description SummaryFounded in 1998, PTC Therapeutics is a global biopharmaceutical company focused on discovery, development and commercialization of innovative treatments that bring benefits to patients suffering from rare diseases.For more than 25 years, PTC have been harnessing its scientific platforms to deliver a number of life-changing therapies to patients that address the underlying cause of multiple rare diseases.PTC has a footprint in more than 50 countries and offices in 20 countries around the world.Director of Regulatory Affairs EUThe Director, Regulatory Affairs – EU is responsible for leading strategically and operationally the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within the European region (including UK). This role includes responsibility for support of EU regional registration and life cycle management regulatory activities. This individual collaborates with the Executive Director, Regulatory Affairs Europe and works closely with the Vice President, International Regulatory Affairs Management. The role is responsible for ensuring that regional regulatory strategies are executed in compliance with current, applicable regulations and standards.He/she manages direct reports.This incumbent works cross-functionally and serves as a liaison between Global Regulatory Affairs team members, other PTC departments, external service providers and contract manufacturers.The Director, Regulatory Affairs – EU ensures for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job DescriptionESSENTIAL FUNCTIONSIn alignment with PTC's global regulatory strategies, leads the development and implementation of regional regulatory strategies for PTC compounds in all stages of clinical and commercial development.Serves as a liaison to regional regulatory Health Authorities including the European Medicines Agency (EMA), the UK MHRA and other national authorities and provides guidance and advice on regulatory and policy developments within the region to PTC's global regulatory team and other key stakeholders. Actively maintains knowledge of regional regulatory requirements (e.g. new regulations, laws, etc.).Defines strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to: Clinical Trial Applications (CTAs); Marketing Authorization Approvals (MAAs) including those required to maintain approvals (i.e. variations, renewals) and customized dossiers for the registration of drug products in countries within the region.Provides regulatory support for country specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for these programs.Collaborates with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations.Ensures that drug products distributed with the region meet local regulatory requirements while also supporting PTC's commercial/business objectives.Provides regulatory support to the Global Pharmacovigilance (PV) organization as necessary to ensure that PTC's PV obligations within the regionare met.Contributes to the organizational design of the regulatory affairs function and contributes to the selection of resources required to meet departmental and corporate objectives. Supports the co-ordination of contracted activities for translation, submission of regulatory documentation and contact with local Health Authorities.Performs other tasks and assignments as needed and specified by management.Knowledge/Skills/Abilities RequiredBachelor's degree in a relevant discipline and a minimum of 8 years of progressively responsible Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment with at least 2 years of successful experience in a regional Regulatory Affairs role.In-depth knowledge of relevant, regional regulatory guidelines and requirements for application in an emerging regulatory landscape.Demonstrated, hands-on experience leading, managing and preparing regional/country-specific regulatory submissions including knowledge of National, Mutual Recognition and Decentralized/Centralized procedures.Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.Demonstrated success gaining regional regulatory approval and in providing regulatory support for post-marketing and life cycle management activities such as variations, renewals and labelling.Experienced providing regulatory support for CTAs and Chemistry, Manufacturing and Control (CMC) related activities.Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.Ability to influence without direct authority.Proficiency with Microsoft Office.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.Fluent in English. Other languages beneficial.Experience in Genetic Disorders, Central Nervous System (CNS), Infectious Disease or Oncology Therapeutic Areas.Experience in rare or orphan disorders research (small patient populations coupled with urgent unmet medical need).Travel requirements0-10 %EEO StatementPTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.#J-18808-Ljbffr
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