job id : 627677600
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Senior Manager, Regulatory Affairs will support regulatory activities for the vaccines portfolio as the regulatory representative on assigned Product/Project Team(s). 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.
II: Responsibilites
• 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
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
• Bachelor’s 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; Interactions with HSA or TGA is desired.
• Ability to work on problems of diverse scope
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
For more details go to URL
