Global Regulatory Manager, oncology

  • Location

    Switzerland

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    75262-PHARM-DEB_1577114483

  • Published:

    10 maanden geleden

  • Duration:

    1 year

  • Expiry date:

    2020-01-22

  • Startdate:

    asap

Reporting to the Director of Regulatory Affairs, the Global Manager of Regulatory Affairs will be a contributor in building a regulatory department. The desired candidate will possess both the depth and breadth to implement and execute on strategies that lead to global approvals of our products. The Global Manager will be responsible for successful execution of regulatory strategy plans. In order to be successful in this role, the person will need to be highly self-motivated, whilst possessing strong work ethic and integrity. The Global Manager must be articulate, an excellent communicator (both verbally and written), able to build relationships and manage to tight timelines.

The Manager has to possess the commercial gravitas to interact with key stakeholders both internally and externally.

Responsibilities

Provides regulatory support for the projects assigned in collaboration with the regulatory lead.
Support submissions, from planning to review - including scientific advice meeting packages, MAA , amendments, variations, annual reports etc..
Represent regulatory in cross-functional discussion and present issues accordingly, where appropriate
Provide guidance to teams in support of regulatory activities for International markets
Participate in activities related to meetings with Health Authorities including preparation and coordination of Briefing packages
Identify issues proactively that will impact programs and provide strategies to address them and communicate to the project team
Provide insight and guidance on implementation of regulations with respect to the preparation and submission of regulatory documentation as well as the design of clinical trials
Create regulatory submission timelines in collaboration with cross functional teams
Provide input into regulatory development plan
Maintains regulatory compliance of OD, PIP, MAA
Abilities Needed for Success
Excellent attention to detail with solid organizational and communication skills, both written and verbal
Motivation and ability to work independently and in a team environment
Positive attitude, energetic and proactive
Ability to provide input to review core documents
Ability to identify and resolve regulatory issues
Strong interpersonal skills and the ability to effectively work with others

Education/Experience Requirements
B.S. in a scientific discipline required
Must have 3+ years of relevant Pharma / Biotech Regulatory Affairs experience
Knowledge of drug development and experience in registration procedures in EU/UK for MAA
Oncology experience desirable, Pharma experience necessary
Previous Exposure to International regulatory issues / Variations required
CV should reflect evidence of in depth experience with interaction with European Health Authorities, (ie. MHRA, EMA, PEI)
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome