Emergent BioSolutions is dedicated to one simple missionto protect and enhance life. As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats. We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

At Emergent Biosolutions Bern, the Swiss affiliate there are - beside manufacturing activities professionals in Quality Assurance and Control, Supply Chain and Regulatory affairs working.  We are heading to the next period of growth with more than 130 professionals working on the Swiss site of Emergent in Bern / Thrishaus. 

The Manager, Regulatory Affairs will support regulatory activities for a product or business unit as the regulatory representative on assigned product teams.  They will work with functional line management and team members across multiple disciplines including nonclinical, clinical and CMC to develop regulatory strategies and manage regulatory submission activities. The Manager, RA will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as planning and executing meetings with regulatory agencies.

With working place in Thrishaus (Berne) this role will report into the Sr Manager, CMC Regulatory Affairs being based in San Diego (USA) and.

Essential Functions

• Represent Regulatory Affairs as the SME on assigned product/ project teams and ensure timely communication of regulatory strategy and plans to team members and line management

• Develop regulatory strategy for assigned products and/or country

• Plan and coordinate the preparation of regulatory submissions including meetings with health authorities and routine correspondence
• Provide critical review of all documentation supporting regulatory applications
• Provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management

• Plan, coordinate, prepare and support meetings and teleconferences with regulatory agencies and submission meetings; may also be required to work with government funding agencies
• Prepare responses to complex questions and comments from regulatory agencies
• Ensure regulatory product compliance for product (e.g. agency commitments)

Qualification requirements

• Bachelors degree in a life sciences or related discipline required.  Approximately 8+ years of relevant pharmaceutical industry experience, with minimum 5 years in Regulatory Affairs.  Less experience acceptable for suitable candidates with relevant industry experience and skill sets.<>
• Must have experience interacting with the FDA, EMA, Health Canada and/or other agencies as required
• Ability to work on problems of diverse scope
• Identifies priorities and key issues in complex situations and solves with minimal assistance
• Exercises judgement within generally defined regulatory practices and policies
• Experienced in leading cross-functional interactions related to regulatory matters
• Effective in both written and oral communication
• Is able to direct work as required and manage complexity
• Thorough knowledge of the development of one or more types of Health Authority regulated products (drugs, biologics, medical devices, combination products)
• Ability to anticipate and prevent potential issues
• Understanding of regulatory issues and their touch points
• Multilingual at least German and English, written and spoken

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

• There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.
• This information is available upon request from the candidate.
• Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions