Associate Director Global Regulatory Affairs – CMC
Location:
Hopewell Township , New Jersey
Posted:
January 12, 2017
Reference:
1600122247W/3-en-us

‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. 
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.

Janssen Research & Development, a member of Johnson & Johnson’s Family of Companies, is recruiting for an Associate Director, Global Regulatory Affairs – CMC with a focus on Small Molecules. The position will preferably be based in Beerse, Belgium.

Janssen Research & Development develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Associate Director, Global Regulatory Affairs – CMC will contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans, with major focus on the Post-approval world. The primary responsibility is to support the regulatory activities related to Small Molecules in all global markets. As Associate Director Global Regulatory Affairs – CMC you will support change requestors and Value Stream Teams and provide direction on the interpretation and application of the different national CMC regulations and guidances related to the change controls coming from the worldwide chemical and/or pharmaceutical plants. Main responsibilities include: preparation of the variation dossiers, amendments, … to the marketing applications of the small molecules; correspondence and direct interaction with local operating companies and Health Authorities and tracking of these changes; commenting on guidance and new regulations; development of product-specific regulatory strategy documents; technical review and approval of reports and other source documents; and other related duties as assigned.

The Associate Director ensures the product strategy meets global regulatory requirements over the lifecycle of the product. Our new Associate Director Global Regulatory Affairs – CMC ensures that the CMC regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy. The Associate Director is also responsible for communication and alignment of the CMC regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader), Value Stream Teams, and all other internal and external stakeholders, and appropriately escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product. Up to 10% travel may be required.

Qualifications
  • At least a Bachelor’s degree in Pharmacy, Chemistry, Biology or a related science/technical field with 10+ years of pharmaceutical industry experience 
  • OR a Master’s degree with 8+ years of pharmaceutical industry experience 
  • OR a PhD degree with 6+ years of pharmaceutical industry experience. 
  • At least 5 years of experience in Regulatory Affairs-CMC is preferred.
  • Knowledge of chemistry, pharmaceutical technology and/or analytical methodologies.
  • Strong knowledge of EU and FDA regulations is required. Knowledge of regulations of other countries is a plus. 
  • Direct and significant regulatory experience in CMC documentation preparation for MAAs, NDAs, … is highly preferred. 
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously. 
  • IT-knowledge with different systems is proficient.
  • Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and leader.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset.  We take your career seriously. 
As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.

Primary Location
Belgium-Antwerp-Beerse
Other Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-California-Fremont
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Regulatory Affairs

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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