Associate Director, Regulatory Affairs

About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).
The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease.
Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg.
Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.
Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates.
Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.
The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer.
Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases.
Position Overview Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and planning for the company’s product portfolio.
This role offers high visibility and working closely with senior management.
The candidate will be responsible for labelling, promotional review, and other post-marketing/commercial regulatory activities, in addition to CMC regulatory activities.
This is a ‘hands on’ position where an individual must be versatile and capable of managing the operational workload that goes along with strategy execution, including: the creation of administrative forms, cover letters, general correspondences; authoring health authority responses alongside subject matter experts; leading cross-functional teams through submission deliverables; managing the routine maintenance of open regulatory applications (INDs and NDAs) with an emphasis on high-quality; and timely submissions to Regulatory Agencies (primarily FDA).
Submission activities include IND's and NDA's/BLA’s including 505(b)(2)), Annual Reports, sales and marketing material, Periodic Adverse Event Reports, Pediatric Study Plans and other regulatory submissions.
This is a fast-paced challenging position offering a competitive compensation and benefits package.
This position will report directly to the Director, Regulatory Affairs and will ideally be based at the Tonix Chatham, NJ or North Dartmouth, MA office with a possibility at another Tonix office or remote location.
Essential Duties · Execute the regulatory strategy for programs in support of company goals · Advise on labelling, promotional review, complaints, adverse events, change control/deviations, annual reports, and other post-marketing/commercial regulatory activities · Provide clear regulatory guidance and risks to product teams and ensures team activities align with defined regulatory strategy · Provide guidance to teams and colleagues to solve problems, achieve goals and meet company defined timelines · Assure connectivity to the overall regulatory strategy through partnership and communication with cross-functional internal and external teams · Serve as the primary point of contact with FDA project manager for assigned projects · Lead the preparation of responses to both U.
S.
and global Health Authorities · Exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate with peers · Author regulatory content including cover letters, administrative forms, draft health authority response documents, and regulatory sections of routine submissions · Provide direction to medical writers assigned to strategic document authorship in line with the defined regulatory strategy · Review cross-functional submission documents for alignment with the regulations, guidance, and strategic goals · Lead strategic and operational aspects of submission work for minor submissions (e.
g.
, IND Annual Report) and major submissions (e.
g.
, initial NDA) · Collaborate with outside contractors · Participate in internal and external cross-functional team meetings · Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s) · Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork · Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives Minimum Qualifications · Bachelor’s degree in a science-related discipline with seven (7) years of relevant experience in the pharmaceutical or healthcare industry preferred · Five (5) years of experience in post-marketing (labelling, promotional review, and other post-marketing/commercial) and CMC regulatory activities preferred · Thorough knowledge of current U.
S.
and global regulations/guidance · Demonstrated identification of key regulatory risks · Thorough understanding of the regulatory process from development through post-marketing · Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands of a variety of R&D, Clinical, QA, Marketing, and Operations team members · Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills · Proven ability to communicate with executive management and external thought leaders · Previous experience with direct report(s) preferred · Highly motivated and comfortable working independently with minimal supervision · Detail-oriented, versatile, and can multi-task and manage changing priorities · Ability for travel 20% of the time · Dedicated team player who is able to withstand the high demands of a fast-paced environment · Excellent written and verbal communication skills are essential · Strong planning and organizational skills · Highly organized, results driven, problem solver, and collaborator · Demonstrated ability to perform the essential duties of the position with or without reasonable accommodation Tonix offers a salary commensurate with experience and an excellent benefits package.
Physical qualifications needed for this job: Constantly- Remaining in a stationary position, often standing, or sitting for prolonged periods.
Communicating with others to exchange information.
Repeating motions that may include the wrists, hands and/or fingers.
Assessing the accuracy, neatness and thoroughness of the work assigned.
Occasionally- Moving about to accomplish tasks or moving from one worksite to another.
Rarely- Ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like.
Moving self in different positions to accomplish tasks in various environments including tight and confined spaces.
Adjusting or moving objects up to 50 pounds in all directions.
Ability to travel via standard modes of transportation Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, disability, veterans status, or any other characteristic protected by law.
In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.
Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.