Associate Principal Scientist (Associate Director) - Regulatory Liaison

About the position The Regulatory Affairs Headquarters Associate Principal Scientist supports products in the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work closely with a global liaison(s) to help develop and implement a global strategy for registration and/or maintenance of VID products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidances or competitive intelligence. Primary activities include, but are not limited to: Assists in regulatory agency communications and submissions, including but not limited to: marketing applications, Investigational New Drug Applications (INDs), pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests. Implements strategy to develop agency background packages and documents associated with regulatory submissions for marketing applications. Communicates with agencies and attending agency meetings to assist the Global Liaison. Participates as an active member on the Global Regulatory Team. They will attend cross-functional meetings as required, in collaboration with, and to assist the global liaison. Conducts research and review of guidelines, regulatory precedence and competitive Intelligence to facilitate development of regulatory strategy. Assists the global liaison in authoring of regulatory strategy documents. Collaborates and communicates regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., Clinical Research, Safety Assessment). Supports maintenance (e.g., quality compliance and life cycle management) of VID programs. Supports of Global Liaison in label development. Assists with process improvement initiatives. Performs regulatory administrative activities as needed.

Responsibilities

• Assists in regulatory agency communications and submissions, including but not limited to: marketing applications, Investigational New Drug Applications (INDs), pediatric plans and annual or other periodic reports.
• Implements strategy to develop agency background packages and documents associated with regulatory submissions for marketing applications.
• Communicates with agencies and attending agency meetings to assist the Global Liaison.
• Participates as an active member on the Global Regulatory Team.
• Conducts research and review of guidelines, regulatory precedence and competitive Intelligence to facilitate development of regulatory strategy.
• Collaborates and communicates regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., Clinical Research, Safety Assessment).
• Supports maintenance (e.g., quality compliance and life cycle management) of VID programs.
• Supports of Global Liaison in label development.
• Assists with process improvement initiatives.
• Performs regulatory administrative activities as needed.

Requirements

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline, or Master’s degree with at least 3 years of relevant experience in pharmaceutical industry, or
• Bachelor’s degree with at least 6 years of relevant experience in the pharmaceutical industry
• Excellent communication skills (both oral and written).
• Good organizational skills with a proven ability to simultaneously balance activities or multiple projects.
• Flexibility required.
• Strong scientific and analytical skills with attention to detail.

Nice-to-haves

• Prior regulatory experience.
• Experience in drug development, particularly anti-infectives and/or vaccine products is highly preferred.

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

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