Regulatory Affairs Manager II

Job Description

Job Summary:

• We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s).
• You will be asked to participate on cross-functional project teams on an agenda-driven basis along with providing support for the client as needed.
• You will support development of US label and work collaboratively with the team to ensure implementation of the US label, which includes providing guidance regarding US labeling precedence to the cross functional teams.
• You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applications, clinical trial applications, and/or marketing authorizations.
• Additionally, you will support the GRL and cross functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and supplemental applications, as needed.

Responsibilities:

• You must exhibit excellent operational competences, including planning, organizing and other project management skills.
• You demonstrate solid oral and written communication skills.
• You can independently build networks with cross-functional team members to support collaboration and generate innovative solutions by identifying Client approaches to address work challenges and opportunities.
• You have knowledge and understanding of applicable regulations, including experience in interpretation of regulations, guidelines, and policy statements.

Qualifications:

• PhD or PharmD with 2+ years of pharmaceutical industry experience in regulatory affairs;
  MS with 4+ years; BS with 5+ years
• Knowledge and understanding of applicable regulations and experience in interpretation of regulations, guidelines, and policy statements
• Excellent operational skills including planning, organizing and ability to represent the department in project teams.
• Ability to work independently with minimal direction and to work well within cross-functional teams
  Solid oral communication and writing skills.
• Develops collaborative relationships to facilitate the accomplishment of work goals.
• Generates innovative solutions in work situations, trying different and Client ways to deal with work problems and opportunities.
• Can build networks to obtain cooperation without relying on authority.