Senior Director - Regulatory Affairs

Location

Piscataway, NJ | United States

Job description

Come Join Our Growing Team!

We are looking for a Senior Director - Regulatory Affairs to join our US team. This role is responsible for p lanning, directing and coordinating regulatory submission activities for sponsors to ensure compliance with regulations and standard operating procedures. You will p lay a leading role in various correspondences with the FDA on behalf of domestic and international sponsors. You will t eam up with US Business Development and China RA to develop various type of regulatory submission businesses globally. You will also w ork closely with the clinical development team to ensure the smooth progression of the clinical trials.

Responsibilities:

• Work closely with clients to formulate a filing strategy prior to the start of any activities to ensure the studies are designed fulfilling the FDA's requirements and tailored to the clients' needs.
• Collaborate with Business Development during contract negotiation to provide insight and guidance regarding scope of work pertaining to regulatory submission.
• Review all regulatory applications for submission; submit sponsor applications, electronically to the FDA.
• Provide responses to regulatory agencies regarding clinical research or regulatory application issues.
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Manage activities such as assistance or coordination of audits, regulatory agency inspections.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
• Train staff in regulatory policies or procedures.
• Develop and maintain procedures for regulatory submission processes and maintenance.
• Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
• Facilitate communication and collaboration internally and/or with the sponsor to ensure mutual clarity among the multidisciplinary teams to ensure the application is clear and precise for regulatory acceptance.
• Facilitate and maintain correspondence with the FDA on behalf of sponsor which may include hosting meetings, phones, calls and/or other necessary regulatory documentation.
• Ensure regulatory application/registration maintenance on behalf of the sponsor.
• Work both internally to assist in regulatory insight for study/protocol development and independently with the sponsor directly on IND submissions relating to clinical studies.
• Act as a U.S. Agent for a foreign establishment to (a) review, disseminate, route, and respond to all communications from FDA including emergency communications; (b) respond to questions concerning those drugs that are imported or offered for import to the United States; (c) assist FDA in scheduling inspections; and (d) If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent.
• Attend project meetings to accommodate external clients or internal customers located at different time zones.
• Coordination of pertinent department or groups for the swift accessibility of the source documents for China RA team for filing purpose.
• Maintain a good relationship and partnership with US Business Development and other Pharmaron functional departments to win their support for RA department and projects.

Competency (knowledge, skills, and abilities)

• Good Clinical Practice (GCP) experience - quality standards that is provided by ICH.
• Demonstrated knowledge of the drug development process, ICH guidelines and the federal codes of regulations on drug products.
• Fluent in Mandarin is essential.
• Good problem solving and people skills.
• Ability to develop partnerships with other internal departments and establish key relationships with external clients.
• Ability to confidently present reports to managers, clients, and regulatory agencies.
• Excellent attention to details and reading/writing comprehension skills.
• Proficient in the use of computer software and databases

About Pharmaron - Who Are We?

Pharmaron is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

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