Rebiotix Inc, part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Located in Roseville, Minnesota, our goal is to improve the lives of patients and reduce the cost of care associated with complex diseases through our innovative microbiota-based MRT drug platform. We are a passionate team of scientists, engineers, and clinical researchers motivated by the opportunity to blaze new trails and create new technologies for today's medical needs. We are looking for like-minded get-it-done individuals to add to our growing team.
The Associate Director will represent Regulatory Affairs for pharmaceutical development projects and marketed products as assigned. The Associate Director will be responsible for development and communication of regulatory strategy on cross-functional project teams, identify and compile required documentation for regulatory submissions, and serve as regulatory subject matter expert to advise colleagues.
Primary Duties and Responsibilities include but are not limited to the following:
Ensure technical accuracy and regulatory compliance of all submissions for assigned projects and ensure that applications are executed appropriately and submitted on time.
Compile information into regulatory documents in consultation with subject matter experts.
Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact company products and operations. Advise personnel in other departments regarding their applicability and impact.
Supports management with development of, and as appropriate, leads implementation of department strategies and policies.
Working with manager, effectively plan, organize, and participate in formal meetings with regulatory agencies as assigned.
Provide interpretive analyses and guidance to teams of complex regulatory situations for which health authority guidance may not yet be available. Advise personnel in other departments regarding their applicability and impact
Forecast risks and develop regulatory strategies.
Proactively manage submissions, including those planned (e.g. annual reports) and unplanned (health authority queries).
Supervise contractors as assigned for regulatory projects; collaborate on marketing application maintenance across multiple geographies and across business units as assigned.
Ability to work across boundaries and exercise influence without direct reporting authority.
Education equivalent to a BS degree or equivalent in a scientific field, microbiology is a plus.
Advanced degree, RAC certification, or PMP certification is a plus.
At least 10 years' experience in Regulatory Affairs.
Prior work on an IND or NDA or BLA (or equivalent).
Analytical thinking and problem-solving skills.
Excellent communication skills, verbal and written.
Excellent interpersonal skills and leadership potential.
Computer literate with knowledge of electronic document programs (Word, Excel, etc).
Operational knowledge of US and ICH regulations and current Good Manufacturing Practices.
Advanced knowledge of US Regulatory Guidance's in support of providing regulatory oversight, direction, and/or analyses to support development activities.
Represent regulatory affairs (viewpoint, analyses, advice) at cross-functional meetings.
Lead or support the regulatory affairs leader at health authority interactions (either in written communications, oral meetings, or otherwise).
Excellent negotiation skills.
Ability to lead others to ensure submissions to the health authorities are accurate, complete, and on time.
Ability to comprehend technical subject matter to support submissions to health authorities.
Project management skills are a plus.
Ability to influence without direct authority.
Resilience and adaptability to a fast-paced environment.
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.