Director of Regulatory Cmc

vor 3 Wochen

Nyon, Schweiz Hobson Prior Vollzeit

**Salary**:
Negotiable**Job type**:
Permanent

**Location**:

Nyon, Schweiz

**Function**:
Regulatory Affairs, CMC

**Posted**:05/04/2023

**Ref**:

BBBH21924
- Hi I'm
Francecsa
, I manage this role

Hobson Prior are seeking for a Director of Regulatory CMC to join a fantastic pharmaceutical corporation on a permanent basis located in Nyon, Switzerland. Our client is focused on offering products and services for severely ill patients.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- In this role, you will be providing global leadership regarding management of submission CMC related documents and CMC regulatory data for Biosimilars.
- You will be responsible for managing assigned project members of the Regulatory Affairs CMC team.
- You will act as RA CMC lead for late-stage projects.
- Responsible for ensuring that Biosimilars Business uses Document and Submission Management System and liaise with the GRA Regulatory Informatics & Submission Management group.
- As Business partner to the Biosimilar CMC team develops, supervises and manages the CMC regulatory activities and CMC submission strategy of Biosimilar dossiers and submissions that best serve the biosimilars business needs.
- You will translate CMC data in regulatory CMC positioning in order to create a comprehensive story line and CMC dossier.
- Provide Regulatory Affairs CMC expertise on Biosimilars for assigned development projects.
- Manage the completion of the relevant Quality documentation to allow timely submissions for the assigned products/countries.
- Manage, plan and finalize responses to Quality questions from Authorities.
- Prepare briefing books and provide support at Regulatory agencies meetings on quality issues.
- Mentor Regulatory professionals in all aspects of Regulatory Affairs CMC Biologics in support of product development.
- Provide support at Regulatory agencies meetings on quality issues.
- Ensure that the input in quality development incorporates the outcome of consultations and negotiations with Regulatory Authorities.
- Ensure that for every manufacturing Change Control Proposal (CCP) the implications have been considered and justify the implementation.
- Carry out regulatory review of study protocols and reports, as well as other relevant regulatory documents intended for the product documentation platform or to local submission. Liaise with authors and data generating functions (as applicable) or data providers.
- Keep up to date with the current regulatory environment and Quality area, coordinate timely implementation of any changes or new relevant laws or guidance; provide comments on new laws on behalf of through the appropriate procedure, as applicable.
- Represent Regulatory Affairs CMC on the project teams for the assigned projects.
- Serve as an interface between company functions as appropriate.
- May support business development opportunities /due diligence.
- Carry out any other tasks as required by the function to achieve its mission and objectives.

**Key Skills**:

- Outstanding written and spoken communication skills.
- Strong interpersonal skills.
- Excellent organisational and planning skills.
- Ability to think strategically.
- Ability to lead and work in teams.

**Requirements**:

- A minimum of 10 years pharmaceutical experience of which at least 8 years in international regulatory with focus on CMC in Biologics.
- Strong understanding of Regulatory Affairs contribution to Pharma business.
- Experience in preparation and coordination of regulatory strategy plans.
- Experience in interaction with regulatory agency in agency meetings for the major agencies (EMA/FDA).
- Experience in analytics or drug substance process development for new biological entities.
- Experience in development of new biologicals or biosimilars.
- Excellent spoken and written English. A second European language would be an advantage.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

  • Director of Regulatory Cmc

    vor 4 Wochen

    Nyon, Schweiz Hobson Prior Vollzeit

    **Salary**: Negotiable**Job type**: Permanent **Location**: Nyon, Switzerland **Function**: Regulatory Affairs, CMC **Posted**:05/04/2023 **Ref**: BBBH21924 - Hi I'm Connie , I manage this role Hobson Prior are seeking for a Director of Regulatory CMC to join a fantastic pharmaceutical corporation on a permanent basis located in Nyon, Switzerland. Our...

  • Director of Regulatory Cmc

    Vor 5 Tagen

    Nyon, Waadt, Schweiz Hobson Prior Vollzeit

    Salary:NegotiableJob type:PermanentLocation:Nyon, SchweizFunction:Regulatory Affairs, CMCPosted:05/04/2023Ref:BBBH2192- Hi I'mFrancecsa, I manage this roleHobson Prior are seeking for a Director of Regulatory CMC to join a fantastic pharmaceutical corporation on a permanent basis located in Nyon, Switzerland. Our client is focused on offering products and...

  • Regulatory Affairs OTC Category Manager

    vor 2 Wochen

    Nyon, Schweiz Haleon Vollzeit

    The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all regulatory...

  • Regulatory Affairs OTC Category Manager

    vor 3 Wochen

    Nyon, Schweiz Haleon Vollzeit

    The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all regulatory...

  • Regulatory Affairs OTC Category Manager

    Vor 5 Tagen

    Nyon, Waadt, Schweiz Haleon Vollzeit

    The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all regulatory...

  • Regulatory Affairs OTC Category Manager

    vor 3 Wochen

    Nyon, Schweiz Haleon Vollzeit

    The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all regulatory...

  • Regulatory Affairs OTC Category Manager

    vor 4 Wochen

    Nyon, Schweiz Haleon Vollzeit

    The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all...

  • Regulatory Affairs OTC Category Manager

    vor 3 Wochen

    Nyon, Schweiz Haleon Vollzeit

    The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all...

  • Regulatory Affairs OTC Category Manager

    Vor 5 Tagen

    Nyon, Waadt, Schweiz Haleon Vollzeit

    The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all...

  • Clinical Research Director

    Vor 5 Tagen

    Nyon, Waadt, Schweiz Haleon Vollzeit

    Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human...

  • Clinical Research Director

    vor 2 Wochen

    Nyon, Schweiz Haleon Vollzeit

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep...

  • Prof Education Director

    vor 2 Wochen

    Nyon, Schweiz Edwards Lifesciences Vollzeit

    We are looking for a Prof Education director who will manage team and activities in professional education to ensure the organization of first-in-class educational programs leading to optimal patient outcomes. **Key Responsibilities**: Establish Edwards SURGICAL as a preferred educational partner to HCPs, societies and education bodies. Manage and oversee...

  • Director, Ethics

    Vor 5 Tagen

    Nyon, Waadt, Schweiz Edwards Lifesciences Vollzeit

    This role will provide pragmatic guidance and solutions related to Edwards' Global Compliance Program to European commercial, medical affairs, and marketing groups as well as functional stakeholders. Relevant compliance areas include Edwards' global business practice framework, in particular on interactions with Health Care Professionals, as well as local...

  • Senior Director, Medical Affairs Eastern Europe, Middle East, Africa

    Vor 5 Tagen

    Nyon, Waadt, Schweiz Edwards Lifesciences Gruppe Vollzeit

    We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Senior Director, Medical Affairs Eastern Europe, Middle East, Africa & Canada page is loaded Senior Director, Medical Affairs Eastern Europe, Middle East, Africa & Canada Apply locations...

  • Senior Director, Medical Affairs Eastern Europe, Middle East, Africa

    vor 2 Wochen

    Nyon, Schweiz Edwards Lifesciences Gruppe Vollzeit

    We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Senior Director, Medical Affairs Eastern Europe, Middle East, Africa & Canada page is loaded Senior Director, Medical Affairs Eastern Europe, Middle East, Africa & Canada Apply locations ...

  • Head of Accounting Control

    Vor 7 Tagen

    Nyon, Schweiz Finders SA Vollzeit

    Client: Part of an international, industrial multinational group, this business unit is headquartered just outside Geneva. It boasts manufacturing sites and sales offices globally and a total population of approximately 1900 employees worldwide. Position: The function reports to the Global Finance Director and will lead a team of 6 direct reports and a...

  • Senior Director, Medical Affairs Eastern Europe, Middle East, Africa

    vor 1 Woche

    Nyon, Schweiz Edwards Lifesciences AG Vollzeit

    Edwards Lifesciences Careers Senior Director, Medical Affairs Eastern Europe, Middle East, Africa & Canada Multiple LocationsSwitzerland-Nyon Canada-Mississauga United Arab Emirates-Dubai type Full time Location Switzerland, Nyon Job reference Req-33811 Posted for 6 Days Share this job Innovation starts from the heart. Edwards Lifesciences is the global...

  • Customer Management Strategy Director

    Vor 4 Tagen

    Nyon, Schweiz Garrett Advancing Motion Vollzeit

    We are pioneers, inventors, and true innovators. The Garrett name has been synonymous with advancing motion by revolutionizing the engine through turbocharger development. Now, as an independent company, Garrett - Advancing Motion (GTX) continues that reputation of being ahead of the technological curve and is completing its offer by vigorously pursuing...

  • Senior Director, Medical Affairs Eastern Europe, Middle East, Africa

    Vor 5 Tagen

    Nyon, Waadt, Schweiz Edwards Lifesciences Vollzeit

    Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes anddiscovering lasting solutions for unmet patient needs. Our...

  • Senior Director, Medical Affairs Eastern Europe, Middle East, Africa

    Vor 5 Tagen

    Nyon, Waadt, Schweiz Edwards Lifesciences Vollzeit

    Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our...