Deputy Responsible Pharmacist
il y a 2 jours
Job Description Summary:
Deputy Responsible Pharmacist / Associate Director Regulatory Affairs, France
The Deputy Responsible Pharmacist (DRP)/ Associate Director Regulatory Affairs, France will join the French affiliate of PTC Therapeutics based in Paris.
The Deputy Responsible Pharmacist / Associate Director Regulatory Affairs reports into the Responsible Pharmacist who reports into the VP International Regulatory Affairs.
The Deputy Responsible Pharmacist / Associate Director Regulatory Affairs will work with the Responsible Pharmacist (RP) to maintain the Pharmaceutical Establishment License and work with all cross-functional counterpart in the French affiliate to support local activities.
The Deputy Responsible Pharmacist / Associate Director Regulatory Affairs deals with complex and sensitive issues with a sense of urgency while communicating to others internally and externally. The incumbent has autonomy to conduct various projects to support both PTC commercial and development products, including the launch of a new product for PKU.
The incumbent ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate
Job Description:
Responsibilities of the role include:
- Acts as Responsible Pharmacist when the Responsible Pharmacist is offsite
- Maintains the quality system (SOP maintenance, handling of deviations, CAPAs, change control and risk management)
- Oversees PTC product supply (distribution and storage requirements, transportation, batch recall) in collaboration with the Responsible Pharmacist
- Collaborates in the pharmaceutical establishment quality review
- Manages technical agreements/contracts in collaboration with the Responsible Pharmacist
- Manages of audits/inspections in collaboration with the Responsible Pharmacist
- Reviews/approves media/promotional material and communication
- Reviews and approves packaging materials
- Reviews, approves and submits educational materials
- Provides regulatory support for country specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for such programs (e.g. compassionate access and early access in France)
- Oversees Pharmacovigilance activities
- Collaborates with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations, as applicable
- Serves as a liaison to regulatory Health Authorities in France and potentially other national authorities in the region and provides guidance and advice on regulatory and policy developments to PTC’s global regulatory team and other key stakeholders
- Actively maintains knowledge of French regulatory requirements (e.g. new regulations, laws, etc.) and shares key insights with the business and global team
- Ensures that drug products distributed with the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives.
- Ensures compliance to anti-gift law and transparency law
Requirements for the role include:
- Knowledge in handling quality records (Deviations, CAPAs, Change Control).
- 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. Experience in US registration would be a plus.
- Experienced providing regulatory support for CTAs and Chemistry, Manufacturing and Control (CMC) related activities.
- Excellent verbal and written communication skills.
- 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 (verbal and written).
- Travel requirements. Occasional national, regional, and international travel which will vary according to ongoing initiatives.
EEO Statement:
-
Paris, France Ultragenyx Pharmaceutical Temps pleinPosition Summary: ultra focused – Work together to fearlessly uncover new possibilities Working directly with the Responsible Pharmacist & Director of Pharmaceutical Affairs France & Benelux, the Pharmaceutical Affairs Manager / Deputy Responsible Pharmacist, will manage the quality system and ensures compliance with applicable pharmaceutical...
-
Executive Assistant to The Deputy Cfo and to The
Il y a 6 mois
Paris, France Moët Hennessy Wines & Spirits Temps plein**Position**: In support of the Deputy CFO: - Maintain and provide a personalised assistance and support, including forward planning, complex diary management - Schedule meetings, corporate conferences, department conference calls - Organise frequent business travels (coordination of hotels, transfers, travel itinerary, visa) - Act as the point of contact...
-
Deputy Editor, English-language Publications Cdi
Il y a 6 mois
Paris, France Reporters sans frontières Temps plein**Deputy Editor, English-language publications CDI (H/F)** Are you looking for a career with meaning? Are you looking for a challenge? Do you want to defend everyone’s right right to free and reliable information? Then come and join us! Reporters Without Borders (RSF) is an independent organisation that defends and promotes the freedom, independence and...
-
Deputy Team Leader Socieux+
Il y a 3 mois
Paris, France Expertise France Temps pleinExpertise France is the public agency of French international technical cooperation. The agency operates around four priorities: - democratic, economic and financial governance; - security and stability of countries in crisis/post-crisis situations; - sustainable development; - strengthening health systems, social protection and employment. In these areas,...
-
Emea Deputy Materials Director
Il y a 3 mois
Paris, France Colas Temps plein**Mission**: - Reporting to the EMEA Materials Director, the EMEA Deputy Materials Director is a key leader responsible for driving the group's MATERIALS activities within the EMEA region. This dynamic role encompasses a diverse range of responsibilities, potentially including: - Circular Economy (Demolition, Inert/Non-inert landfilling, Soil Remediation...
-
Deputy Mlro
Il y a 6 mois
Paris, France Bank of America Temps plein**Job Title**:Deputy MRLO **Corporate Title**: Director **Location**:Paris **Company Overview**: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our clients, teammates, communities and shareholders every...
-
Fr-deputy Local Safety Officer
Il y a 2 mois
Paris, France Daiichi Sankyo Europe Temps plein**Passion pour l'innovation. Compassion pour les patients.**: Avec plus de 120 ans d'expérience et plus de 17 000 collaborateurs dans plus de 20 pays, Daiichi Sankyo se consacre à la découverte, au développement et à la mise à disposition de nouveaux standards de soins qui enrichissent la qualité de vie dans le monde entier. En Europe, nous nous...
-
Country Patient Safety Head
Il y a 2 mois
Paris, France Novartis Temps plein**Summary**: In collaboration with the global patient safety and local leadership, establish and drive Patient Safety (PS) strategy and operational excellence at country level, in compliance with the national and international regulations/standards/guidelines and corporate procedures, for all marketed and investigational products - drugs and medical devices...
-
IT Support team lead deputy
Il y a 4 mois
Paris, France Imerys Temps pleinJob Summary JOB PURPOSE Imerys is a world leader in creating speciality solutions that improve everyday life through minerals. Our success is built on our people and creating an environment where our 17,500 employees around the globe can thrive. We passionately believe that our teams are at their best when they have the opportunity to learn, collaborate...
-
Commercial Compliance
il y a 2 jours
Paris, France Syneos Health Commercial Solutions Temps plein**Description** **Overview** This position is responsible for leading the implementation of effective compliance program operations that support one or more of the Company’s commercial lines of business and managing a team of compliance professionals and/or support personnel devoted to the execution and oversight of the program. **Responsibilities** -...
-
Associate Director Pharmacovigilance
Il y a 6 mois
Paris, France Organon Temps pleinFor our Organon office in Paris we are currently looking for an: **Associate Director Pharmacovigilance / Local Qualified Person for Pharmacovigilance** To lead a team of 4 Pharmacovigilance Specialist. You will act as a Local Pharmacovigilance Qualified Person/ local responsible person for pharmacovigilance (QPPV/ LRPV) as required by local legislation....
-
Project Manager
il y a 4 semaines
Paris, Île-de-France Institut Curie Temps pleinAt Institut Curie, we are seeking a highly skilled Project Manager to join our team and contribute to our mission to accelerate the fight against cancers affecting young people. The Project Manager will report hierarchically to the Director of the SIREDO center, working closely with the deputy director for translational research, the deputy director for...
-
Strategic Marketing Professional
il y a 4 semaines
Paris, Île-de-France CSL Temps pleinAbout the RoleWe are seeking a Strategic Marketing Professional to support the launch and commercialization of two flu vaccines in France. As part of CSL Seqirus and Vifor France, a joint venture between CSL companies, you will be responsible for creating effective cross-functional omnichannel brand strategies.Key ResponsibilitiesSupport the Marketing Lead...
-
Manager of Credit Analysis
il y a 1 mois
Paris 8e, France China Construction Bank (Europe) S.A. Paris Branch Temps plein**General Description**: The main responsibilities of CM is to support both CIB & FI RMs to develop business. It plays a vital role in business development. It serves as the key first line of defence, receiving the client's data, and ensuring that information is securely saved and archived. **Main Duties and Responsibilities**: - Fully cooperate with risk...
-
Socieux+ Associate Programme Officer
Il y a 6 mois
Paris, France Expertise France Temps pleinExpertise France is the public agency of French international technical cooperation. The agency operates around four priorities: - democratic, economic and financial governance; - security and stability of countries in crisis/post-crisis situations; - sustainable development; - strengthening health systems, social protection and employment. In these areas,...
-
Cdi - Senior Research Executive (F/H)
Il y a 6 mois
Paris, France LVMH Holdings Temps plein**Position**: Within the Media Research Image department, LVMH is seeking a Research executive to support LVMH maisons in providing strategic competitive analysis with regards to earned media and media efficiency measurement. **Primary mission**: Under the supervision of the Deputy Media Research Director, the Senior research executive will coordinate PR...
-
Deputy Head of Financial Controlling
Il y a 3 mois
Paris, France AXA Temps pleinRéférence de l’offre 240008PO Type de contrat CDI Niveau d'expérience Expérimentés Société du groupeGIE AXA Famille métierFinance et stratégie Localisation PARIS **Votre rôle et vos missions**: Whatever their stage of life, we provide over 108 million customers with the products and services they need to progress. From insurance to...
-
Pharmaceutical Business Development Manager
il y a 3 semaines
Paris, Île-de-France CSL Temps pleinCSL Seqirus and Vifor France are seeking a highly motivated Pharmaceutical Business Development Manager to support the launch and commercialization of two flu vaccines in France. The successful candidate will be responsible for working closely with cross-functional teams to develop and execute effective cross-functional omnichannel brands strategies,...
-
Deputy Head of Financial Controlling – Europe
il y a 1 mois
Paris, France AXA Temps pleinWhatever their stage of life, we provide over 108 million customers with the products and services they need to progress. From insurance to personal protection, and savings to wealth management, no matter the need we’re always there for them. And we’re always there for our employees. In 50 countries, we work hard to inspire pride and a sense of belonging...
-
Supply Chain Coordinator
Il y a 6 mois
Paris, France Médecins sans frontières Temps pleinMédecins sans Frontières (MSF) is an international, independent, medical humanitarian, organization that delivers emergency aid to people affected by armed conflict, epidemics, natural disasters, and exclusion from healthcare. MSF offers assistance to people based on need, irrespective of race, religion, gender or political affiliation. Médecins sans...