Sr Manager/Director of Regulatory Affairs

SUMMARY:





Juvaris BioTherapeutics, Inc. is developing and commercializing therapeutic vaccines and immunostimulants for the treatment of infectious diseases, cancer and severe allergy using its novel technology platform.  The development stage company is seeking a Director of Regulatory Affairs to implement and conduct all regulatory activities.  Develop and implement strategies for earliest possible approvals of phase 1 through phase 4 applications.  Provide professional expertise and strong leadership in the development and implementation of regulatory strategies, including meetings with domestic and international regulatory authorities, CMC, clinical trial functions, and issues related to biological product development, submissions, and compliance.

 

DUTIES AND RESPONSIBILITIES:





Specific activities include, but not limited to the following:

·        Plan, organize, and prepare documents and regulatory submissions for domestic and international product development and registration.

·        Work with management to develop, plan, organize and implement regulatory strategy.

·        Participate in product planning to assure timely, smooth, and efficient development of regulatory submissions for clinical trials and product registration. 

·        Provide regulatory guidance to functional area to ensure understanding, rapid and effective development of regulatory document requirements needed for timely submissions.

·        Primary interface with regulatory agencies.

·        Establish SOPs for effective operation of the Regulatory Affairs department, including interfacing with other departments to oversee/coordinate the development of regulatory procedures and controls to ensure product compliance in a timely manner.

·        Ensure timely preparation of organized and scientifically valid submissions, including INDs, to appropriate governmental agencies to meet regulatory requirements.

·        Coordinate all related government and compliance activities within the organization during and after inspections, or during regulatory actions by government agencies.

·        Recommend appropriate regulatory changes for labeling, manufacturing, and marketing to assure regulatory compliance.

·        Remain current with all regulatory requirements and standards necessary to develop and obtain licensure for therapeutic vaccines.

  

JOB REQUIREMENTS:





Skills required in the following:

·        Strong cross-cultural communication skills.

·        Ability to manage contract personnel.

·        Strong organizational skills.

·        Detail oriented.

·        Ability to prioritize and handle multiple tasks simultaneously.

·        Ability to work independently and in a team environment.

·        Dedication to quality and reliability in all work tasks.

·        Self motivation, eagerness to grow professionally and commitment to self-development.

·        Willingness to travel domestic & international as necessary, consistent with the project needs.

 

EDUCATION AND EXPERIENCE:

 

·        Bachelor’s degree with minimum of 7 years applicable experience in the regulatory affairs of biological products, MS degree preferred.

·        Extensive knowledge and understanding of laws, regulations, and guidelines pertaining to new drug development/vaccine therapy and registration.

·        Knowledge of US and International regulatory practices and procedures.

·        A minimum of ten years of experience in positions of increasing scope and responsibility in regulatory affairs (including regulatory oversight of CMC and Clinical Trials).

·        Must be familiar with cGMP/GLP, GCP and Regulatory Guidelines as applied in start-up and mature biopharmaceutical companies.

·        Must have successful experience in preparation of INDs, CTDs, NDAs, BMFs, and BLA submissions, including amendments.

·        Demonstrated experience having primary responsibility for major regulatory submission including successful FDA interface/negotiations.

·        Demonstrated ability to lead managers, consultants and others from product discovery and research through approval and product introduction.

·        Regulatory Affairs Certification (RAC) desirable.

 

COMPENSATION:

 

Salary base will be competitive with the field and experience.  Compensation package includes base salary, stock options, vacation time, sick leave, paid holidays and benefits.  Benefits include medical, dental, vision, life insurance, short-term and long-term disability insurance, flexible spending account plan and 401(k) plan.