Executive Director, Regulatory Affairs
Iovance Biotherapeutics, Inc.
4 hours ago
Remote
United States
Corporate Functions
Executive Director, Regulatory Affairs
Responsibilities:
- Support development and execution of global regulatory strategy for pipeline and approved products.
- Ensure strong regulatory and compliance position in all necessary jurisdictions.
- Maintain relationships with relevant regulatory agencies to improve submission quality and track pending/proposed regulatory changes.
- Lead preparations for pre- and end-of-Phase, scientific advice, and advisory committee meetings.
- Communicate directly with regulatory authorities to expedite submissions, review, and approval.
- Work with contract regulatory organizations to prepare applications, respond to queries, and maintain development activities.
- Assure compliance with applicable regulations.
- Identify risks; interpret and communicate relevant issues to project team members and senior management.
- Educate/train employees on regulatory matters to ensure compliance.
- Maintain knowledge of global competitive landscape, regulatory environment, and applicable regulations/guidance.
Required Qualifications:
- Bachelor’s Degree with 15+ years’ experience; or an advanced degree (Life Sciences, MD, PhD, or PharmD) with management experience and 10+ years’ experience.
- Knowledge of global regulations and guidance related to global regulatory strategy.
- Proven ability to implement worldwide regulatory strategies.
- Strong track record collaborating with FDA and other key global agencies to achieve successful business outcomes.
- Excellent verbal and written communication skills.
- Ability to work in a team environment, report on projects, and drive them to conclusion.
- Self-starter with urgency; strong team player across disciplines.
- Adaptability, flexibility, independence, and resourcefulness.
Skills/Knowledge (also includes):
- Judgment, troubleshooting, problem-solving, analysis, discretion; ability to handle stress, multiple priorities, and deadlines.
Work Environment:
- Professional or remote office environment; use standard office equipment/keyboards.
Physical Demands (summary):
- Remain standing/sitting for prolonged periods; occasional lifting/carrying up to 10 lbs; visual acuity; repetitive hand/wrist/finger motion; ability to communicate with others.
Responsibilities:
- Support development and execution of global regulatory strategy for pipeline and approved products.
- Ensure strong regulatory and compliance position in all necessary jurisdictions.
- Maintain relationships with relevant regulatory agencies to improve submission quality and track pending/proposed regulatory changes.
- Lead preparations for pre- and end-of-Phase, scientific advice, and advisory committee meetings.
- Communicate directly with regulatory authorities to expedite submissions, review, and approval.
- Work with contract regulatory organizations to prepare applications, respond to queries, and maintain development activities.
- Assure compliance with applicable regulations.
- Identify risks; interpret and communicate relevant issues to project team members and senior management.
- Educate/train employees on regulatory matters to ensure compliance.
- Maintain knowledge of global competitive landscape, regulatory environment, and applicable regulations/guidance.
Required Qualifications:
- Bachelor’s Degree with 15+ years’ experience; or an advanced degree (Life Sciences, MD, PhD, or PharmD) with management experience and 10+ years’ experience.
- Knowledge of global regulations and guidance related to global regulatory strategy.
- Proven ability to implement worldwide regulatory strategies.
- Strong track record collaborating with FDA and other key global agencies to achieve successful business outcomes.
- Excellent verbal and written communication skills.
- Ability to work in a team environment, report on projects, and drive them to conclusion.
- Self-starter with urgency; strong team player across disciplines.
- Adaptability, flexibility, independence, and resourcefulness.
Skills/Knowledge (also includes):
- Judgment, troubleshooting, problem-solving, analysis, discretion; ability to handle stress, multiple priorities, and deadlines.
Work Environment:
- Professional or remote office environment; use standard office equipment/keyboards.
Physical Demands (summary):
- Remain standing/sitting for prolonged periods; occasional lifting/carrying up to 10 lbs; visual acuity; repetitive hand/wrist/finger motion; ability to communicate with others.