Pharmaceuticals, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
The Senior Manager/Associate Director, Regulatory Affairs, will possess a strong foundation in the regulatory profession, including scientific, legal, policy and regulatory process management. The person in this position will have well-developed regulatory technical knowledge and skills necessary to lead the development, implementation, and influence regulatory strategy for small molecule, systemic, investigational drugs, including global marketing application submission strategy and clinical trial support. The person in this position will provide hands-on leadership and oversight for regulatory operations activities and work closely with project teams to provide regulatory guidance. This person will work closely with external vendors that provide regulatory support along with direct reports.
Provide regulatory support for new and ongoing clinical trials (e.g., clinical trial applications and import licenses, provide input for clinical protocols, labels, and other study related materials)
Maintain current awareness of relevant global regulatory requirements and identify and assess global regulatory risks and mitigation plans and communicates changes in regulatory information to departmental and team colleagues
Coordinate regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs, etc.
Provide hands-on support in generation of regulatory documents (e.g., Module 2 and Module 3 of CTD, IMPD, etc.)
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.
Ensures that the clinical and nonclinical data—in conjunction with regulatory strategy—are consistent with the regulatory requirements and support the proposed product claims.
Provide support for cGXP activities as the relate to regulatory affairs (e.g., inspections)
Provide support for responding to queries from health authorities and for preparing for meetings with regulatory agencies
Monitors the progress of the regulatory authority review process through appropriate communication with the agency
Demonstrate commitment and support for company goals, objectives and procedures
Represent Reata by developing collaborative relationships with site personnel, colleagues and vendors
Demonstrate professionalism and adherence to moral, ethical and quality principles
Participate in corporate and departmental meetings
Comply with applicable regulations, GCP and corporate policies and procedures
Experienced professional with a minimum of 7 years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs in both early and late stage development programs
Excellent technical writing and communications skills with strong background in oral small molecule pharmaceutical development, manufacturing, and regulatory writing
Direct regulatory filing experience required (e.g., IND(s)/NDA(s)/BLA(s) or equivalent)
Knowledge and understanding of applicable global regulations is required
Excellent attention to detail, and strong computer and organizational skills required
Strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills
BA/BS, MS, or PhD in relevant technical discipline
Internal Number: 001
About Reata Pharmaceuticals, Inc.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.