The Director of Regulatory Affairs provides strategic global regulatory guidance to cross-functional project teams responsible for product development. The successful candidate has a proven track record in the development of drugs, biologics/vaccines, and also in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project teams to execute the agreed-upon strategies; supports departmental activities with regards to clinical trial conduct and regulatory submissions.
MAJOR ACTIVITIES AND RESPONSIBILITIES
Reporting to the Senior Director of Regulatory Affairs and CMC, the Director will:
· Actively lead development and implementation of regulatory strategies for assigned programs and ensure cross functional alignment.
· Lead regulatory activities (nonclinical, clinical and CMC) to assure timelines and milestones.
· Interface with Commercial Regulatory Affairs developing GRASP’s.
· With support of Commercial RA, develop initial product labeling and assess proposed product claim proposal (pre-NDA).
· Interface with Business Development conducting due diligence and assessing commercial viability of potential drugs.
· Provides Regulatory Risk Assessment (RRA) during various phases of product development.
· Monitor current and proposed regulatory and legal issues, and ensure that key initiatives are communicated to the stakeholders.
· Coordinate all aspects of regulatory submissions relevant to assigned programs, including coordinating regulatory workflow, reviewing technical documents (nonclinical, clinical, and CMC), developing and tracking submission timelines, and supervising preparation of regulatory submissions to ensure compliance with regulations and guidelines. It is expected that the Director will also have some experience outside the US.
· Review and approve protocols, reports, and documents used in regulatory submissions.
· Prepare IMPD to support international CTA submissions.
· Lead as a key member of Global Regulatory Project Teams.
· Lead multidisciplinary team responding to Health Authority questions during the IND and NDA review phases for assigned projects.
· Act as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., contract research organization teams and vendors).
· Support Quality Assurance activities during pre-approval GCP and GMP FDA/EMEA/PMDA inspections.
· Work with development partners as required; assist in due diligence activities.
· Expand and precede the organization's policies and procedures for regulatory affairs and compliance to establish a compliant culture.
· Maintain knowledge and monitor changes in pertinent laws, regulations and guidance. Interpret external developments and inform/educate internal stakeholders.
· Identify the need for new regulatory policies, processes and SOPs, approve and ensures implementation.
· Works closely with Regulatory Operations to ensure e-CTD compliance.
QUALIFICATIONS AND BACKGROUND REQUIREMENTS
Ph.D. or Pharm. D. or equivalent experience in a scientific discipline or equivalent will be preferred. Bachelors or Master’s Degree will be considered with relevant experience in Regulatory Affairs. Regulatory Affairs Certification is favorable.
Professional Work Experience
· Minimum of 8-10 years of regulatory experience respectively within the pharmaceutical or biotechnology (preferred) industry.
· Experience with designing and executing creative development strategies for NCE and biologics development programs.
· Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
· Comprehensive understanding of FDA regulations and ICH guidances, as well as comprehensive experience in the drug development process.
· Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in electronic Common Technical Document format.
· Experience with international clinical trials and regulatory documentation.
· Excellent communication (written and verbal) and collaboration skills.
· Expertise in translating regulatory requirements into practical, workable plans.
· Experience in preparation of critical submission documentation, and communications with FDA and other regulatory agencies.
· Ability to build effective relationships within a team/collaborative environment, with a high level of professionalism.
· Proven track records working with regulatory agencies.
· Able to travel as required within a global work environment.
Open from: 5 Oct 2020
Type of employment: Full Time