Position: 13914 Manager Grace Benedict

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 140 professionals working on the Swiss site of Emergent in Bern / Thrishaus. 

The

Sr Manager, Regulatory Affairs

will support regulatory activities for the Vaccine Business Unit as the regulatory representative on assigned Product Teams.  He/she 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 Sr. Manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as leading, planning and executing meetings with regulatory agencies.

With working place in Thrishaus (Berne) this role will report into the Director Regulatory Affairs being based in San Diego (USA)

Main responsibilities

• Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders
• Develop innovative regulatory strategies that incorporates risk identification and mitigation
• Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions
• Oversee development of submission content, documents and timelines
• 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
• Lead meetings both in-person and teleconferences with regulatory agencies for specific projects; may also be required to work with government funding agencies
• Negotiate complex issues with regulatory agencies and prepare responses to questions and comments from regulatory agencies
• Ensure regulatory product compliance for assigned products (e.g. agency commitments)
• As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
• Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to assigned programs. Interpret existing regulations and guidance documents for regulatory department and/or project teams. Conduct and analyze regulatory research to understand competitor activity
• Interact with company partners and consultants for various regulatory matters as needed
• As required, develop procedures to support the regulatory affairs department
• May provide input to business unit strategies from regulatory perspective
• May be responsible for a functional area and/or have direct reports

Qualification requirements

• Bachelors degree in a life sciences or related discipline required.  Approximately 10+ 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 regulatory agencies
• 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