Job Details

Senior Regulatory Affairs Manager

Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are aligned with company strategies and achieve operational objectives to gain product approvals.

Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to all company personnel.

Lead, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization.

Oversee preparation and filing of all regulatory documents with the FDA, CDE and other regulatory agencies.

Develop and maintain external relationships with key opinion leaders and regulatory officials.

Direct the development of systems, practices, and processes to ensure effective ongoing review of clinical development plan, product design and/or manufacturing changes and adverse events.

Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk.

Responsible for company's product quality and reliability to meet or exceed regulatory.

Lead company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards.

Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities.

Support the quality system, provide effective leadership support, training, and guidance to all company personnel.

Serve as the ambassador to and develop strategies for responses to regulatory related inquiries from global regulatory agencies and ensure issues are addressed in a timely manner.

Responsible for leading all regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures.

Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions.

Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management.

Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible.

Champion initiatives that contribute to global process improvements, which have a significant impact on business.

Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization's (CRO's), material suppliers, consultants, and vendors.

Other projects or responsibilities as may be required.

A PharmD or PhD degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and international regulatory agencies is required for this position.

Minimum 10-15 years of progressively responsible Regulatory experience in a pharmaceutical, biotechnology or related environment. Position also requires a minimum of 5-8 years of leadership experience in a global regulatory affairs role.

Must have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business.

Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP GMP, CLP guidelines and relevant requirements

Substantial experience in all aspects of regulatory affairs, including Clinical, Commercial support, CMC, with a track record of successful submissions and license approvals with CDER and CBER

Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions.

Excellent working knowledge of the US, European and Asian regulations for drugs and biologics.

Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.

Must be able to travel (US/international) up to 25%.

RAC Certification preferred