Regulatory Affairs Director, Anovent Pharmaceuticals (Recruitment Information of Shanghai Anovent Pharmaceutical Co.,)

Anovent Pharmaceuticals is an innovative company which is focusing on the research, development, production and sales of respiratory medicines. As an international pharmaceutical company in respiratory area, Anovent is dedicated to provide affordable respiratory medicines for patients worldwide.

Primary role of regulatory affairs (RA) director is to lead Anovent regulatory affairs team, provide RA strategies and ensure RA objectives achieved successfully for Anovent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Ø  Lead the development and implementation of the regulatory strategy, and ensure global and/or regional regulatory team to achieve the regulatory objectives in line with qualities and timelines.

Ø  Lead the management, planning, coordination, and preparation of documents that are submitted to regulatory authorities (including FDA, EMA, etc), in support of ANDAs, DMFs, etc.

Ø  Serve as the primary interface with regulatory authorities on assigned projects, and prepare project/study team for regulatory authority meetings, as required.

Ø  Represent regulatory affairs on various cross-functional teams, and work with cross-functional teams to define contributions to submissions, and represent regulatory affairs in senior management discussions and present issues accordingly.

Ø  Monitor changes in the regulatory environment, both general and specific to the therapeutic area, interpret and communicate regulatory expectations to internal and external stakeholders in order to execute objectives in compliance with applicable regulations.

Ø  Lead the development and maintenance of Regulatory Affairs working practices and procedures.

Ø  Lead the skill-development, coaching, and performance feedback of other regulatory staffs working on the products/projects.

Requirements

Ø  Master degree or above in related disciplines.

Ø  2+ years’ work experience in regulatory affairs of pharmaceutical industry or related area.

Ø  Generic drug experience highly preferred, especially in US ANDA.

Ø  DPI or inhalation product experience highly preferred.

Ø  Strong understanding of overall drug development and global/regional regulatory science, with a focus on US ANDA processes.

Ø  Good computer skills.

Ø  Strong ability in English, including listening, speaking, reading and writing.

Ø  Excellent leadership skills.

Ø  Demonstrated ability for critical thinking, problem-solving and innovation.

Ø  Strong interpersonal skills to ensure effective communication, collaboration and negotiation.

Ø  Strong project management and organizational skills, prioritizes and plans work activities.

        Contact information

        Anna He     Tel: 13816142073      mail:annahe9999@126.com