Regulatory Affairs Specialist

REGULATORY AFFAIRS SPECIALIST

Description:

Roles and Responsibilities:

• You will provide regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally

• Typically a 1st line manager of professionals or a 2nd line manager of a professional department. Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource. Has awareness of latest functional developments in own area. Contributes towards strategy and policy development, and ensures delivery within area of responsibility.

• Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.

• Impacts approaches, projects and programs in the functional area or affected business organization and ways of working. Impacts quality, efficiency and effectiveness of own team. These jobs have significant input into their priorities. Jobs at this level tend to be covered by professional practices and policies but these are shaped by the role. Working within broad guidelines and policies, roles at this level have moderate autonomy, requiring high levels of evaluative judgment.

• Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.

Additional Skills & Qualifications:

Required Qualifications

• Bachelor’s degree in a scientific discipline; post-graduate degree preferred.

• 6+ years’ experience of global regulatory affairs from the pharmaceutical and/or healthcare industry with a track record in key strategic roles.

• Experience of regulatory submissions and approvals in key regions such as EU, US and APAC, including new MAAs/NDAs.

• Significant experience of global regulatory project management and world-wide regulatory authority interactions.

 Benefits:

• Medical, Dental & Vision Plans
• 401k
• Paid Holiday & Vacations
• Employee Assistance Program
• Corporate discounts and much more!

Contact Us:

Please email a copy of your resume and 2-3 professional references to mscherlacher@actalentservices.com