Johnson & Johnson Careers

CHINA - Regulatory Affair Manager

China
Regulatory Affairs


Job Description

Requisition ID: ACT1800001D

Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a  Regulatory Affair Manager  in Beijing. As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.     Job Responsibilities   ·          Expedites the registration of new products/line extension/claims and supports the marketing activities of the business units, while ensuring local regulatory compliance. ·          Prepares and manages regulatory submissions to the local Health Authority throughout drug development, registration and life cycle management in close collaboration with Global DRA and with CRO partners. ·          Develops, communicates and implements regulatory strategies for earliest possible approval of regulatory submissions, including clinical trial application and for marketed product support in close collaboration with Global DRA. ·          Identifies and defines key regulatory issues related to preclinical and clinical development, manufacture, sale (including pricing and reimbursement issues) and post approval surveillance of approved products in close collaboration with Global DRA. ·          Ensures compliance of company products and activities with local guidelines and codes (e.g. Labelling, advertising/promotion) ·          Coordinates and supports interactions between the company and health authority/regulatory agency representatives and CRO partners to facilitate clinical trial application and NDA programs through development to approval and during life cycle management ·          Answers regulatory questions from health authorities in close collaboration with Global DRA and CRO partners. ·          Works closely with Global DRA for all regulatory matters and submissions and provides ongoing regulatory input. ·          Develop and maintain relationship/partnerships with local Health Authority and Professional Association/Organization. ·          Keeps abreast of, and implement, changes in national and international regulatory requirements and processes. ·          Act as internal consultant on drug regulatory matters.

 


Qualifications

Candidate Requirements ·         Life sciences degree (preferable pharmacy degree). ·         Fluent English (both oral & written). ·         Minimum of 5 years experience with regulatory affairs activities in multi-national pharmaceutical company. ·         Profound knowledge of national health authority and industry regulations, policies and guidelines. ·         Understanding of the drug development process. ·         Negotiation skills, project management skills. ·         Outstanding persuasiveness, influencing and coordination skills. ·         Effectively working in team within a country and globally. ·         Ability to manage complex communication issues and to establish fruitful working relationships to partners internally and externally.   If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.

 

 


Primary Location
China--
Organization
Janssen Pharmaceuticals, Inc (6062)
Job Function
Regulatory Affairs
Requisition ID
ACT1800001D