SEARCH CAREER OPPORTUNITIES

GENERAL SUMMARY OF POSITION:

MassBiologics, located in Boston, is the only non-profit, FDA-licensed manufacturer of vaccines in the United States. For over 100 years, MassBiologics has worked to improve public health through applied research, development and production of biologic products.

The Associate Deputy Director, Regulatory Affairs is responsible to develop and oversee strategic approaches to ensure that MassBiologics’ IND and licensed products meet regulatory agency requirements and industry current practices both nationally and internationally.

For more information please visit our website:

www.MassBiologics.org

MAJOR RESPONSIBILITIES:

• Designated as MassBiologics’ authorized representative to the US FDA and international regulatory agencies as applicable.

• Leads negotiations as primary liaison with regulatory agencies.

• Responsible for establishing fiscally responsible organizational strategy to ensure regulatory compliance in all jurisdictions where MassBiologics places its products as well as strategies to support CMO client products.

• Ensures that all aspects of MBL-sponsored clinical trials meet regulatory requirements. Set and prioritize project timelines.

• Manages the coordination and preparation of document packages for all regulatory submissions, internal audits and FDA inspections. Includes, but is not limited to, Biologic License Applications and Amendments (BLAs), Establishment License Applications and Amendments (ELAs), Investigational New Drug (IND) Applications and Amendments, responses to all FDA queries and inspections, labeling Transmittals for Product Labels, Circulars and Promotional and Advertising Materials.

• Oversees all regulatory submissions, license applications, and renewals required by regulatory agencies. Ensures that the proper documents have been compiled and submitted.

• Oversees regulatory document tracking systems and initiates new and improved tracking systems to meet organization’s goals

• Provides input to the MassBiologics Quality System by providing technical input to the deviation and change management processes to assure consistency with current regulatory status or to initiate an appropriate regulatory submission.

• Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance and ensures the changes are completed.

• Maintains current knowledge of all applicable regulations. Responsible for circulating information to Senior Staff. Provides expert analysis and evaluation of regulations.       Evaluates risk, impact and analyzes trends of government regulatory activities.

• Ensures that reports of Adverse Events are documented appropriately, circulated to appropriate personnel, tracked internally and submitted to FDA as needed. Submit Periodic Adverse Event Report for all licensed products every January.

• Prepares and submits annual reports for active IND products and BLAs.

• Directs Clinical Trials Operations ensuring that clinical trials are executed in accordance with MassBiologics strategy, scientific plan and Good Clinical Practices.

• Ensures that all aspects of MBL-sponsored clinical trials meet regulatory requirements. Set and prioritize project timelines.

• Performs additional job related duties as required

REQUIRED QUALIFICATIONS:

• Requires a doctorate degree (PhD, MD) and demonstrated senior leadership experience or a Bachelor’s degree and 15 years experience including senior management experience. Prior experience as a senior leader of regulatory affairs for a Biologics Manufacturing organization is required.

• Demonstrated ability to effectively manage: processes, others, performance, and set and prioritize departmental goals

• Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple teams, multiple projects and meet deadlines

• Excellent written and verbal communication skills

• Excellent customer service skills

• Experience in any of the following areas preferred: IND submissions, BLA submissions and ELA applications/amendments, submissions to regulatory agencies in other countries

• May require frequent travel between the Mattapan and Fall River campuses

• May require national and international travel

• Ability to work extended and sometimes unusual hours to meet business needs.

Must be able to carry out the essential functions of this position, with reasonable accommodation if disabled