Summary of Position: 

The Director International Regulatory Affairs is responsible for developing and delivering innovative, breakthrough regulatory strategies for product development and approval, with a focus on regions outside of the USA. The individual will work closely with the Executive Director Regulatory Affairs to develop the global regulatory strategy for assigned programs.  The individual has strong experience in the global development of infectious disease products and worked on CTAs and/or MAAs.

Essential Duties and Responsibilities:

•     Responsible for directing global regulatory strategies for assigned programs, with a focus on regions outside of the USA.

•     Provide regulatory guidance to product development teams across all programs, in addition to functioning as the regulatory liaison with regulatory agencies (e.g. EMA, SwissMedic, MHRA, Health Canada, PMDA).

•     Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. Obtain actionable regulatory feedback from health authorities.

•     Work efficiently with Contract Research Organizations and Site Management Organizations to implement regulatory strategy globally.

•     Collaborate with product development teams on the development and/or optimization of product development strategy to be consistent with regulatory requirements.

•     Provide regulatory guidance to company personnel throughout the research and development process. 

•     Plan submissions and dossier/package strategies per the product's global regulatory strategy for CTA/INDs, NDA/MAAs, international Marketing Applications, Health Authority meetings, etc.

•     Identify and assess regulatory risks associated with product development and define strategies to mitigate risks.

•     Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.

•     Anticipate the impact of the changing regulatory environment on development plans and registration strategy. Develop and implement strategies to proactively influence/address these changes.

Qualifications:

•     Experience in a International Regulatory Lead role for the development of drugs (infectious disease therapeutic area preferred).

·       Proven track record in ex-US regulatory filings, approvals, and strategic planning.

•     Understanding of global regulatory agencies processes for drug development and in line maintenance (e.g. EMA, SwissMedic, MHRA, Health Canada, PMDA).

·       Experience managing regulatory submissions and operations

•     Ability to communicate clearly and concisely with senior management and regulatory authorities.

•     Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities.

•     Excellent and proven negotiation skills.

•     Ability to effectively work in a team environment and develop peer relationships.

•     Excellent writing and verbal communication skills.

Education & Experience

•    Degree in a scientific/technical discipline (BS, MS, PhD or PharmD) with a minimum of 10 years pharmaceutical drug development experience and 5 years hands-on regulatory experience.

•     Must have strong experience in development of infectious disease INDs, CTAs, NDAs, and/or MAAs. 

•     Sound understanding of ICH and major markets' regulations.

Pay range - $180,000 - $240,000