This position will be the Regulatory lead on the company's highest profile asset. This organization is mid-sized, and has seen significant success with multiple approved products and continued innovation in areas of small molecules, biologics and gene therapy - all with a focus on rare disease!

Responsible for providing global regulatory leadership and direction in support of the development, registration, and life-cycle management of innovative programs for rare diseases. The individual will provide oversight of the content and preparation of all regulatory documents/submissions related to applicable programs and mentor junior members of the regulatory team. This position will report to Vice President, Regulatory Affairs (clinical/nonclinical strategy).

Responsibilities

· Provides regulatory leadership in support of the development, registration, and life-cycle management of products (both early-stage and late-stage development) for rare diseases.

· Provides strategic regulatory direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management and Health Authority interactions. Represents Regulatory on Program Core Teams as applicable. Leads regulatory sub-teams as required.

· Liaises and negotiates with global regulatory agencies (e.g. FDA, EMA, Health Canada) as needed for all aspects pertaining to drug development including novel regulatory pathways for the company’s rare disease products, resolution of key regulatory issues and to expedite approvals of products.

· Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones.

· Provide critical review of documents related to clinical and nonclinical aspects of programs to ensure messaging is consistent with program strategy.

· Maintain knowledge of and monitor changes in current global rules, regulations, and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).

· Initiate or contribute to local and/or global process improvements which have a significant impact on business.

Requirements

· Minimum BA/BS degree in life sciences. Advanced degree preferred.

· Strong scientific background with at least twelve (12) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.

· Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.

· Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies.

· Thorough understanding of global drug development regulations and guidelines.

· Proven ability to successfully manage major submissions and critical projects to deadlines.

· Proven ability to successfully interact with regulatory authorities.

· Experience in the preparation and filing of marketing applications is highly desirable

· Experience with development of drugs/biologics for rare diseases is preferred.