Regulatory Affairs Director / Senior Director

Careers

Regulatory Affairs Director / Senior Director

Job Code: USRA01
Position: Regulatory Affairs Director/ Senior Director
Department: Regulatory Affairs
Reports to: VP, Regulatory Affairs
Location: Remote – West Coast based

Company Profile:

Connect Biopharma (Nasdaq: CNTB) is a global, clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research.  With operations and expertise in China, the United States and Australia and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology.

Job Summary:

The Regulatory Affairs Director/ Senior Director is an experienced professional who will formulate and implement regulatory strategy, provide guidance to program teams and sub-teams, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet business needs.  This role has remote capability for anyone located on the West Coast. The ideal candidate will bring extensive knowledge and understanding of the regulatory submission process to a growing global team focused on immunology.

Responsibilities

  • Provide regulatory leadership to support the development, registration, and life-cycle management of company products in both early-stage and late-stage development.
  • Represent Regulatory on project teams and provide strategic regulatory direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, issue management and Health Authority interactions.
  • Lead sub-teams to efficiently develop and coordinate complex and high-quality regulatory submissions such as briefing documents, INDs, CTAs, supplements, amendments, and responses to agency questions.
  • Plan and manage routine submissions such as annual reports and investigator documents while also handling urgent submissions as needed.
  • Liaise and negotiate with global regulatory agencies (e.g. FDA, EMA, Health Canada) for all aspects on drug development including novel regulatory pathways, resolution of regulatory issues, and to expedite approvals of products.
  • Manage preparation for Health Authority interactions including coaching team, assessing potential alternate positions, and working to ensure readiness for optimum outcomes from agency interactions.
  • Assess CMC regulatory strategy to understand proposed changes, new development efforts, and other related activities emphasizing requirements and working to coordinate timelines with other project activities.
  • Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
  • Manage relationship with external consultants/CROs supporting regulatory operations and development of study start up activities.
  • Actively manage department policies and procedures including development and implementation of SOPs and Work Instructions to ensure compliance with requirements and improved efficiency.
  • Maintain knowledge of and monitor changes in current global rules, regulations, and published guidance governing drugs and biologics in all phases of development, and knowledge of therapeutic area(s).
  • Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
  • Manage relationship with external consultants/CROs supporting development of study start up activities.
  • May participate in due diligence assessments in collaboration with business development.

Education

  • Minimum BA/BS degree in life sciences.

Skills/Experience

  • Strong drug development background with at least ten (10) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
  • Deep knowledge of regulations and GCP concepts governing pharmaceutical development; understanding of relevant guidance documents (e.g. FDA, ICH, EMA)
  • Experience with both large and small molecules preferred; understanding of CMC requirements and principles of GMP expected.
  • Strategic thinker and problem-solver capable of providing advice and sound regulatory recommendations which may have long-term impact; adept at identifying risks, decision making, implementing plans and risk mitigation strategies with strong leadership, negotiation and influencing ability.
  • Excellent attention to detail with solid coordinating, task planning and time management skills; outstanding verbal, written and interpersonal communication skills.
  • Able to work effectively in both a collaborative and an independent manner in a global start-up environment; must interact in proactive, honest, and productive manner while focusing on milestones, compliance, and key decisions needed to advance programs.
  • Proven ability to successfully manage major submissions and critical projects to meet deadlines and successfully interact with regulatory authorities to manage key milestone meetings for products (eg. Pre-IND, EOP2, pre-BLA)
  • Experience with development of drugs/biologics for immunology-related diseases and combination products (prefilled syringe/auto-injector) is preferred.
  • Experience in the preparation and filing of marketing applications (BLA/NDA/MAA) is highly desirable.
  • Excellent proficiency with MS Office software including document versioning, styles/templates, and publishing concepts for Acrobat documents; experienced in internet research (e.g., competitive products, labeling, regulation/guidance); familiarity with principles of document management, archiving, and eCTD systems.

We offer our employees the opportunity to grow individually while working collaboratively to make a difference in the lives of the patients we seek to serve.