Job Detail

Associate Director, Global CMC Regulatory Affairs180000CO 

Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for an Associate Director, Global CMC Regulatory Affairs in  Allschwil . Other locations may be considered.

 

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 hypertension (PH). Our portfolio of PH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

 

The Global CMC Regulatory Associate Director is responsible for developing global CMC regulatory strategies and content plans according to scientific/risk-based principles in consultation with their supervisor.

 
 
Role Responsibilities 

• Ensures the development strategy meets global regulatory requirements over the lifecycle of the product.


• Ensures CMC regulatory strategy is in alignment with the global regulatory strategy,


• Therapeutic Area portfolio, regional strategies, commercial strategy, and the Quality Target Product Profile (QTPP).


• Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).


• Participates as the Regulatory CMC Lead on CMC/VST Teams and represents Global CMC


• Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally


• Refines regulatory strategies as new data become available.


• Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product.


• Leads the preparation of regulatory dossiers for submission to health authorities.


• Actively participates on Global Regulatory Team(s) to develop global submission plans.


• Provides accurate regulatory assessments of chemistry, manufacturing and control changes to teams/projects and executes regulatory planning and implementation.


• May provide oversight of assigned staff.

 

Candidate Requirements

• Minimum BSc in engineering, biological, pharmaceutical, or chemical sciences with Pharm.D or Ph.D preferred


• 7+ years of relevant progressive experience in CMC / technical regulatory affairs.


• Demonstrated ability to communicate regulatory requirements.


• Strong knowledge of global HA laws, regulations, guidance and the regulation submission routes available for assigned products.


• Experience developing regulatory strategies and an understanding of product development


• Expertise in product development and its application in global regulatory strategy.


• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical


• Industry


• Experience leading interactions with health authorities under supervision of a senior member of the CMC RA staff.


• High-level verbal and written communication skills, fluent in English.


• This position will require approximately 10% travel, both international and domestic.

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.

 

Primary Location

: CH-BL-Allschwil

Schedule

: Full-time

Job Posting

: Aug 17, 2018

Job Type

: Standard

Job

: Quality