Director, Regulatory Affairs Promedior
THIS JOB HAS EXPIRED Reports to: Chief Medical Officer
Education: B.S./M.S. or Ph. D. in Chemistry, Biology or related discipline
Experience: Ten to 15 years of experience. Established reputation with global Regulators, oversight of CTAs and INDs to support development of biologic products. Regulatory submissions from pre-IND through Phase 3 studies. Registration experience and/or orphan drugs a plus.
The successful candidate will be a primary contact with global Regulatory agencies for all ongoing development programs. The candidate should have an established record in regulatory strategy and operations for the execution of clinical development and registration of novel biologics. Driving results through successful meetings with Regulators at key stages of development including pre-IND/CTA, End of Phase 2, Scientific advice/Protocol Assistance, and pre-BLA/MAA. Knowledge and/or experience in orphan product development a significant plus.
The candidate must be results driven, and be able to make independent decisions on the basis of data and regulatory feedback in order to keep projects on track and on time. This person will lead and manage the oversight of regulatory activities for both clinical development and CMC issues, using internal resources and third party CROs. An in-depth understanding of the regulatory requirements for each stage of clinical development of protein therapeutics is essential as is direct experience in authoring and successfully submitting regulatory documents to both the FDA and European agencies. This position requires strong leadership and problem solving skills as well as excellent communication skills in English, particularly with respect to project management. Ideally, the candidate will have direct experience in oncology and/or ophthalmic IND submission and execution.
This person will be responsible for input into overall strategy for project development including preparing development plans, budgets, and directing and coordinating the operational and logistical activities of regulatory operations in the development of products, projects and programs in accordance with SOPs and GCP, GMP, ICH and FDA guidelines and established budgets and timelines.
Management of regulatory relationships with key Agencies for both strategic issues and day-to-day communications.
In-depth knowledge and demonstrated experience in regulatory submissions including authoring, editing, reviewing and submission of regulatory documents through NDA/BLA submission.
Ability to work with senior management and the business unit to construct world wide regulatory strategies and achieve product development goals.
Driving results through successful meetings with Regulators at key stages of development including pre-IND/CTA, End of Phase 2, Scientific advice/Protocol Assistance, and pre-BLA/MAA. Preparation of meeting documentation and meeting management.
The ability to supervise external regulatory CRO?s in order to meet company goals and timelines
In-depth knowledge of GMP, GCP, ICH and both FDA and EMEA guidelines for the investigation and approval of new biologic drug products from IND through BLA/MAA.
Can keep abreast of changes in the regulatory environment and implement necessary adaptations
Knowledge and/or experience in orphan product development a significant plus, including orphan designations and ongoing requirements.
Strong written and oral communication skills
Ability/willingness to work in an entrepreneurial, dynamic small company environment
||Boston, MA |
THIS JOB HAS EXPIRED