Director of Regulatory Affairs Eu

vor 4 Wochen

Home Office, Schweiz PTC THERAPEUTICS Vollzeit

Job Description Summary:
Founded 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 EU

The 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 Description**:
ESSENTIAL FUNCTIONS
- In 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 REQUIRED:
Bachelor’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.
- Special knowledge or skills needed and/or licenses or certificates required.
- 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.
- Abili

  • Director Global Clinical Affairs- Immunodiagnostics

    vor 3 Wochen

    Home Office, Schweiz Thermo Fisher Scientific Vollzeit

    **Location: EMEA-Remote** **Division Summary**: The **ImmunoDiagnostics Division (IDD)** develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 2,000 employees worldwide, IDD is the global leader in in vitro allergy testing and also the European leader...

  • Regulatory Affairs Scientific Leader

    vor 3 Wochen

    Home Office, Schweiz Dechra Pharmaceuticals PLC Vollzeit

    Job Introduction Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC. Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide. Here...

  • Associate Director, Regulatory Cmc

    vor 2 Wochen

    Home Office, Schweiz Apellis Pharmaceuticals Vollzeit

    **Position Summary**: We are looking for an** Associate Director, Regulatory Affairs CMC **to join our team. We are expanding our existing group of exceptionally talented and well-motivated colleagues to develop and commercialize This position will be responsible for developing and executing CMC regulatory strategies to support the expansion into...

  • Director, Eu Field Operations

    vor 3 Wochen

    Home Office, Schweiz BeiGene Vollzeit

    General Description: The Director of EU Field Operations will support the commercial field operations and technical needs across Europe. The incumbent will partner with local markets, EU leadership, and the Global COBA organization to provide expertise and insights as a strategic and tactical partner in support of the implementation of EU and local market...

  • Regulatory Affairs Associate Europe

    vor 3 Wochen

    Home Office, Schweiz BeiGene Vollzeit

    General Description:_ BeiGene is seeking a highly motivated and fast-learning person to support the expansion of clinical trials in Europe in view of clinical trial regulations. This individual will be responsible for timely planning and coordination of regulatory submissions. The Associate will assist the Regulatory Affairs team member on cross-functional...

  • Executive Director, Head of Regulatory Affair New

    vor 4 Wochen

    Home Office, Schweiz BeiGene Vollzeit

    General Description Responsible for strategic and operational regulatory support of BeiGene’s entry into our new market territories worldwide, with dotted reporting line to the Head of New Markets (i.e. LATAM, MENA, Eastern Europe and Africa). Accountable for managing the assigned regulatory affairs teams to drive the regulatory activities of all BeiGene...

  • Director, Regulatory Information Management

    vor 3 Wochen

    Home Office, Schweiz BeiGene Vollzeit

    General Description: The Director, RIM is responsible for partnering with internal and external stakeholders in executing the RIM strategy and vision for the organization. This includes activities related to RIM resources, planning and budgeting (in partnership with IT), for key systems implementation/upgrade, monitoring and analysis of submission and...

  • Mgr, Regulatory Intelligence

    vor 3 Wochen

    Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit

    **Description** **JOB SUMMARY**: The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities...

  • Global Regulatory Combination Products Lead

    vor 3 Wochen

    Home Office, Schweiz Sobi Vollzeit

    **Key Responsibilities** - Lead New Product Development for medical devices (including companion diagnostics) and drug/device combination products to ensure compliance when placed on market - Manage the creation and maintenance of regulatory documentation to support compliance including device technical files - Provide expert advice to internal and external...

  • Business Development Director

    vor 2 Wochen

    Home Office, Schweiz Clinigen Vollzeit

    Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world. We are currently 1,100 people headquartered in the UK with...

  • Business Development Director

    vor 3 Wochen

    Home Office, Schweiz Luminary Group Vollzeit

    Our client is a leading global life science consulting firm specializing in helping pharmaceutical, biotechnology, and medical device companies navigate the complex landscape of the healthcare industry. We provide strategic guidance and innovative solutions to our clients, enabling them to bring life-saving products to the market. We are seeking a highly...

  • Associate Director Scientific Communications

    vor 3 Wochen

    Home Office, Schweiz Sobi Vollzeit

    We are looking for a dedicated new Scientific Affairs team member to take the role of Associate Director Scientific Communications pegcetacoplan, starting immediately. This role is a permanent position that will be based or report to the Stockholm Headquarter office, and will report to Emmelie Persson, Senior Director Head of MACS pegcetacoplan The...

  • Managing Director

    vor 3 Wochen

    Home Office, Schweiz BiTechnologies Vollzeit

    **Job Title**: Managing Director - Securities Lending & Private Banking (Success Fee-Based) **Location**: Remote/International (Europe, Asia, China) **Job Type**: Success Fee-Based with Performance Bonuses **About Us**: BiTechnologies is an innovative investment firm specializing in healthcare, biotechnology, real estate, energy and capital markets. We...

  • Sales Director C&r Uk/eu

    vor 4 Wochen

    Home Office, Schweiz Luxoft Vollzeit

    **Project** Description**: We are currently looking for Sales Director for Consumer & Retail industry to manage and grow business with leading Retail, Logistics, eCommerce, CPG, Transportation and Travel customers to meet DXC Luxoft's targets from both sales and annual revenue targets (with clear profitability). **Responsibilities**: Identify new sales...

  • Associate Clinical Science Development Director

    vor 3 Wochen

    Home Office, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Position Overview** The Associate Director, Clinical Development Science provides clinical development expertise into a multi-disciplinary team engaged in advising clients in early through late-stage development of medical products. Inpout will be provided into the design and...

  • Executive Medical Director in Oncology

    vor 2 Wochen

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** Here at Syneos Health, we are looking for an **Executive Medical Director to work sponsor dedicated. **You will have the chance to work in exciting studies in Oncology. The job location is** Home Based in France or Netherlands.** **Summary** This position is responsible for providing leadership and establishing strategy and implementing...

  • Director Global Multilateral Engagement, Global

    vor 3 Wochen

    Home Office, Schweiz Pfizer Vollzeit

    Director Global Multilateral Engagement, Global Health Partnerships (M/F/d) permanent position from Geneva region/ Remote You can look forward to: This position reports to the Head of Global Health Partnerships responsible for supporting the divisional multilateral stakeholder engagement strategy and ensuring alignment with our enterprise global health...

  • Sr Biostatistician

    vor 2 Wochen

    Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit

    **Description** **Senior Biostatistician (Medical Affairs Ophthalmology)** - **Previous experience within Ophthalmology is required** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address...

  • Director of Product Automotive

    vor 2 Wochen

    Home Office, Schweiz SMG - Swiss Marketplace Group AG Vollzeit

    Welcome to SMG Swiss Marketplace Group AG We are the pioneering network of online marketplaces in Switzerland and a leading European digital company that simplifies people's lives with forward-looking products. Our exciting portfolio currently spans four business areas and includes; Real Estate (immoscout24, homegate, ImmoStreet, home, Acheter-Louer,...

  • Director, Gxp Learning

    vor 3 Wochen

    Home Office, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Position Summary**: The Director of GxP Learning & Document Management is responsible for leading the strategic development, implementation, and oversight of comprehensive GxP (Good Practice) training programs and documentation management standards across the organization. This...