Mapp Biopharmaceutical
  • San Diego, CA, USA
  • Full Time

 

Senior Director of Regulatory Affairs

Job #19-01R

 

 Mapp Biopharmaceutical, Inc. "Mapp" is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Senior Director of Regulatory Affairs will be responsible for developing and leading CMC regulatory strategies and activities for the organization, including the CMC sections of regulatory submissions. This position will serve as a key member of the CMC leadership team and the regulatory team, and may provide regulatory support for other disciplines as needed.

Basic Qualifications:

  • PhD (or equivalent) with 5 years prior experience in a technical role in the CMC function, as an analytical lead or downstream process (DSP) or upstream process (USP) lead for a mAb, or MS (or equivalent) with 7-10 years in a technical role in the CMC function as an analytical lead or DSP or USP lead for a mAb, or BS with 10- 15 years in a technical role in the CMC function, as an analytical lead or DSP or USP lead for a mAb
  • 7-10 years of experience in regulatory affairs in pharmaceutical/biotech industry with a focus on CMC activities and CMC Regulatory Affairs
  • 5+ years of demonstrated success in regulatory team leadership role and proven management by influence
  • Prior monoclonal antibodies or protein therapeutics BLA filing experience
  • Direct experience with FDA
  • Demonstrated experience managing complex virtual and matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
  • Demonstrated experience in developing effective and successful regulatory strategies for the CMC organization
  • Direct experience in leading a mAb/protein therapeutic through the drug development process through BLA submission, approval, and launch of the product
  • Must have direct experience in written and verbal interactions and negotiations with FDA related to CMC issues/submissions
  • Experience in establishing portfolio and program CMC Regulatory strategy from pre-Candidate Selection through Post-Licensure
  • Thorough drug development technical expertise in all aspects of CMC
  • Experience in commercialization of monoclonal antibody therapies
  • Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner
  • Ability to provide effective project communications, verbal and written, tailored for specific audiences
  • Ability to translate complex information into a logical and credible plan
  • Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities
  • Demonstrated organizational skills and attention to detail
  • Familiarity with eCTD requirements and e-submission formats/processes

Preferred Qualifications:

  • Advanced degree or equivalent in a related field
  • Experience in interacting and negotiating with non-US Regulatory Agencies
  • Experience with post-approval change management, comparability assessment, post-marketing commitments and overall product life cycle management
  • Experience with FDA Animal Rule requirements for licensing drugs
  • Experience with US government acquisition and procurement contracting and Project Management deliverables
  • Experience in supporting US Government grant or proposal planning and writing
  • Previous experience in labor and capacity planning
  • Previous experience establishing effective working relationships in a virtual environment
  • Previous experience with mentoring and/or development of employees
  • Previous experience developing drugs for rare diseases/Orphan drugs
  • Previous experience with FDA's regulations on expanded access to investigational drugs
  • Previous experience working with regulatory authorities in developing countries and in resource limited environments
  • Previous experience developing good working relationships with regulators at all levels of the FDA especially in CMC related areas
  • Ability to effectively work remote/virtual (if applicable) using telecons and web conferences to both interact with product development teams, direct reports, and senior management

Responsibilities

  • Ensures that all CMC regulatory goals are met and are in compliance with current industry standards and global regulations, and are effectively networked with government funding stakeholders.
  • Serves as the global steward of CMC Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the CMC organization
  • Participates in the development of regulatory strategies for the company as well as for product development teams
  • Acts as a key member of the product development, CMC and regulatory leadership teams at Mapp
  • Serves as the CMC regulatory representative to drug substance/product development teams and provide input to key development decision and documents
  • Ensures that all CMC regulatory goals are met and are in compliance with current industry standards and global regulations, and are effectively networked with government funding stakeholders.
  • Serves as the global steward of CMC Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the CMC organization
  • Participates in the development of regulatory strategies for the company as well as for product development teams
  • Acts as a key member of the product development, CMC and regulatory leadership teams at Mapp
  • Serves as the CMC regulatory representative to drug substance/product development teams and provide input to key development decision and documents
  • May act as the primary point of contact with Health Authorities on CMC matters. Facilitates CMC interactions, presentations and negotiations and is responsible for the oversight of CMC interactions with Health Authorities.
  • Develops effective working relationships with the regulators at the leadership level and not just the transactional level
  • Interprets and communicates FDA (and other regulatory body) messages pertaining to CMC matters, expectations and decisions to internal and external stakeholders (including CRO's, CMO's, consultants and contractors) on a timely basis
  • Advises senior management on the impact the changing regulatory environment can/will have on Mapp business and project
  • Participates in portfolio and program-level strategy establishment, decision-making, issue resolution, communications strategy, and resourcing/capacity evaluations as the CMC Regulatory Affairs representation

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Travel (~20%) will be required for this position. Mapp wants you to join their team and invites you to apply.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

Mapp Biopharmaceutical
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