Regional Regulatory Lead

vor 3 Wochen

Bern, Schweiz CSL Behring Vollzeit

The Regional Regulatory Representative is responsible for all regional regulatory strategic and operational tasks for a range of products in the assigned Therapeutic Areas (TA) and Intercontinental (ICO) Region (Latin America, Eastern Europe (non-EU), Middle East and Africa).

In consultation with the Therapeutic Area Lead, Regional Regulatory Lead contributes to global regulatory strategies, develops and executes regional strategies.

**Responsibilities**:

- Act as a Regional Subject Matter Expert for regulatory procedures and requirements
- Develop regional regulatory strategies considering regional requirements and priority settings
- Participate in Global Strategy Teams as required
- Build strong relationship and collaboration with Local Regulatory Representative and internal stakeholders (e.g., Commercial, Manufacturing, Supply Chain and Medical Affairs)
- Ensure timely regulatory activities in the region are in alignment with the global instructions and strategy
- Contribute to the compilation of high-quality documentation for all submissions and correspondences
- Support Subject Matter Experts for the preparation of response for questions from Health Authorities
- Contribute to the development and maintenance of strong working relationships with regional Health Authorities, demonstrated by high quality communication and effective use of negotiation and influencing skills to achieve positive outcomes for CSL
- Stay current with international legislation and guidelines for any biological products and other key related CSL activities and initiatives (e.g. rare diseases, orphan drugs, toll manufacturing)
- Collaborate to training materials creation or updates if needed
- Collaborate to any process improvements as required

**Qualifications**:

- A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
- At least 5 years of regulatory experience within the Intercontinental region, supported by additional pharmaceutical /industry experience.
- Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP and GCP.
- English mandatory, and additional language is an asset (Arabic, French, Spanish, Russian )

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

  • Regional Regulatory Lead

    Vor 6 Tagen

    Bern oder Zürich, Schweiz Swisslinx Vollzeit

    On behalf of our client, an international biopharmaceutical company, Swisslinx is looking for a Regional Regulatory Lead. If this is you, you will serve as Lead for the assigned product portfolio and countries. Contract type: initially 12 months, extension very likelyStart Date: 1st AugustLocation: Bern OR Zurich, SwitzerlandWorkload: 100%Work type: hybrid,...

  • Regional Regulatory Lead 100%

    Vor 5 Tagen

    Bern, Bern, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For our client we are looking for a Regional Regulatory Lead (Therapeutic area Immunology, Respiratory, Transplant) (m/f/d) 100% Tasks & Responsibilities:Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries.Align all regulatory activities with regional and global...

  • Regional Regulatory Lead 100%

    Vor 6 Tagen

    Bern, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For our client we are looking for a Regional Regulatory Lead (Therapeutic area Immunology, Respiratory, Transplant) (m/f/d) 100% Tasks & Responsibilities:Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries.Align all regulatory activities with regional and global...

  • Regional Regulatory Lead Haematology

    Vor 2 Tagen

    Bern, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For a worldwide leading biotherapeutics company in Bern we are looking for aRegional Regulatory Lead Haematology (f/m/d)Temporary employment, 100%Tasks and responsibilitiesServe as a Regional Regulatory Lead for the assigned product portfolio (therapeutic area Haematology) and countriesAlign all regulatory activities with regional and global strategies,...

  • Regional Regulatory Lead Haematology

    Vor 5 Tagen

    Bern, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For a worldwide leading biotherapeutics company in Bern we are looking for aRegional Regulatory Lead Haematology (f/m/d) Temporary employment, 100%Tasks and responsibilitiesServe as a Regional Regulatory Lead for the assigned product portfolio (therapeutic area Haematology) and countriesAlign all regulatory activities with regional and global strategies,...

  • Regional/local Regulatory Lead

    Vor 5 Tagen

    Bern, Bern, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkRegional/Local Regulatory Head LBDOur client, a large pharmaceutical organization, is looking for a Regional/Local Regulatory Head for a 12-month contract (with possibility of extension) in Bern.Responsibilities: Support GRA Region Intercontinental team members to obtain and maintain registration of products within ICO Region...

  • Regional/local Regulatory Lead

    Vor 5 Tagen

    Bern, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** **Regional/Local Regulatory Head - 5373 LBD** Our client, a large pharmaceutical organization, is looking for a **Regional/Local Regulatory Head** for a** 12-month contract (with possibility of extension) in Bern**. **Responsibilities**: - Support GRA Region Intercontinental team members to obtain and maintain...

  • Ass. Director, GRA Regional TA Lead

    Vor 6 Tagen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Purpose:We are looking for an experienced and experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contributing to global regulatory strategies, and submitting regulatory applications for development products and change applications for registered products to...

  • Ass. Director, GRA Regional TA Lead

    Vor 2 Tagen

    Bern, Bern, Schweiz CSL Behring AG Vollzeit

    Job Purpose:We are looking for an experienced and experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contributing to global regulatory strategies, and submitting regulatory applications for development products and change applications for registered products to...

  • Ass. Director, GRA Regional TA Lead

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    Job Purpose:We are looking for an experienced and experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contributing to global regulatory strategies, and submitting regulatory applications for development products and change applications for registered products to...

  • Ass. Director, GRA Regional TA Lead

    Vor 7 Tagen

    Bern, Schweiz CSL Behring Vollzeit

    Job Purpose:We are looking for an experienced and experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contributing to global regulatory strategies, and submitting regulatory applications for development products and change applications for registered products to...

  • Ass. Director, GRA Regional TA Lead

    Vor 2 Tagen

    CH-3014 Bern CSL Behring AG Vollzeit

    Job Purpose: We are looking for an experienced and experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contributing to global regulatory strategies, and submitting regulatory applications for development products and change applications for registered products to...

  • Global Regulatory Study Lead

    vor 4 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    In order to complete our team of team of experts in Global Regulatory we our looking for a Global Regulatory Study Lead. In this challenging and important role you will be expected to: 1) Lead CTA activities for global clinical trials during the entire study lifecycle - Develop the CTA submission strategy for clinical trials - Act as an accountable interface...

  • Regional Regulatory Scientis for Csl Behring

    vor 2 Wochen

    Bern, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of expertise in the personnel services sector. Its recruitment activities are focussed on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the...

  • Lead Counsel Regulatory, Safety

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    **Purpose**: Lead counsel responsible for providing and coordinating specialist legal advice on safety and pharmacovigilance matters in CSL’s key jurisdictions, and strategic and specialist legal advice on regulatory matters. **Responsibilities**: - Provide specialist legal advice to CSL’s Global Regulatory Affairs (GRA) and Global Clinical Safety &...

  • Global Regulatory Affairs Digitalization Lead

    vor 4 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, haematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Global Regulatory Affairs...

  • Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Lead / PV Auditor

    vor 4 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Responsibilities: The Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Lead / PV Auditor is responsible for leading and coordinating the Global PVRQA activities in the respective region (Americas, Asia-Pacific (APAC), European Economic Area (EEA), ECI) under the general direction of the PVRQA Regional Head, to ensure that CSL's (CSL Behring / CSL...

  • Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Lead / PV Auditor

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Responsibilities: The Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Lead / PV Auditor is responsible for leading and coordinating the Global PVRQA activities in the respective region (Americas, Asia-Pacific (APAC), European Economic Area (EEA), ECI) under the general direction of the PVRQA Regional Head, to ensure that CSL's (CSL Behring / CSL...

  • Global Regulatory Affairs Digitalization Lead

    Vor 6 Tagen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, haematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.Global Regulatory Affairs is...

  • Regional Lead, Legal Services

    vor 4 Wochen

    Bern, Schweiz CSL Vollzeit

    The Opportunity As the Regional Lead, Legal Services EMEA, you'll help foster meaningful relationships and driving collaboration across all levels of our organization and with our external partners. You will focus on creating a positive and engaging experience throughout the contracting process, ensuring agreement, transparency, and mutual benefit for...