Sr Manager Regulatory Affairs

Emergent BioSolutions in

  • Type: Full Time
position filled
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Job Description

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

 Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Work in multiple locations. 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. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Employer's Job# 28422

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