Manager/ Sr. Manager, Regulatory Affairs

Job Summary:

Reporting to the Executive Director of Regulatory Affairs, the successful candidate will manage regulatory responsibilities associated with the development, support, and manufacturing of MEI’s investigational drug products, as well as contribute to the development and execution of successful regulatory submissions to support investigational products for new or active US and global oncology clinical studies. This candidate will also represent the regulatory affairs group as part of cross-functional teams to provide regulatory support and guidance. This candidate will support routine and complex regulatory submissions to help maintain and achieve timelines.

Role and Responsibilities (included but not limited to):

• Supports study start-up activities with reviews of essential regulatory packets and provides guidance to clinical teams.
• Helps ensure regulatory commitments are tracked and met within appropriate timeframes.
• Provides regulatory support for clinical health authority submissions and responses globally.
• Supports and executes on regulatory strategies for assigned programs in the areas of Oncology and Hematology drug development and lifecycle management.
• May represent regulatory affairs in cross-functional team meetings.
• May provide regulatory expertise on specified topics cross-functionally.
• Conducts specified research activities to support regulatory topics essential for the business.
• Provides organization and project management activities for routine and complex submissions.
• Remains current on applicable regulations and guidances.
• May support interdepartmental teams in the review of high-quality regulatory documents/submissions.
• Ensures compliance with regulatory procedures and work practices.
• Identifies, drafts and reviews Regulatory Affairs SOPs, as necessary, and develops a working knowledge of internal SOPs.
• Ensures technical accuracy and regulatory compliance of all submissions.
• Innovates, analyzes and solves problems in conjunction with regulatory affairs team members.

Qualifications:

• Highly ethical with uncompromising personal integrity.
• Critical thinker and creative problem solver with excellent organizational skills.
• Ability to perform in a fast-paced, dynamic environment.
• Excellent influential, collaborative and interpersonal skills.
• Can deal calmly and objectively with complexity and time pressures.
• Team player and diplomatic
• Knows when to come for answers – knows what one doesn’t know
• Know audience and tailor’s communication style to each

Job Requirements and Education:

• Minimum of a BS degree in a scientific discipline.
• At least 5 years’ experience within a pharma, biopharma or biotechnology company – oncology desired
• Experience in Phases 1-3 and commercial product lifecycle
• Knowledge of Good Clinical Practices
• Capable to diplomatically lead or participate in team discussions
• Excellent communicator, orally and written
• Strong negotiating and problem-solving skills
• Proven ability to deliver results within business defined timeframes
• Proven ability to effectively work collaboratively in cross-functional team discussions
• Strong project management and organizational skills

Employment type: Full time

ADA Notations:

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
• Regular communication (hearing/speaking).
• Lifting up to 25 lbs.
• Routine office duties including computer keyboard use.
• Vision requirements include close vision and the ability to focus.
• Noise conditions range from quiet to moderate.