Sr Manager, Regulatory Affairs
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.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• 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 nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM 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
• 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
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical/Mental Demands and Work Environment Characteristics:
☒ Ability to organize/coordinate ☒ Comprehend and follow instructions
☒ Direct, control and plan ☒ Independently make quick decisions to solve complex issues
☒ Problem Solve ☒ Analyze/Interpret data and information
☒ Perform with frequent interruptions ☒ Make decisions using sound judgment
☒ Supervise/Manage others
☐ Good eye/hand coordination ☐ Visual Acuity
☒ Use keyboard/computer/phone ☐ Detect/Distinguish smell
☐ Detect/Distinguish hearing ☐ Maintain stationary position
☐ Position self to move ☐ Move/Traverse
☐ Ascend/Descend (climb) ☐ Reaching
☐ Calibrate precise ☐ Ability to safely operate hand tools
☐ Move/Transport [X] lb. ☐ Repetitive movement activities
☒ Regular and predictable attendance
☐ Work around extreme temperatures – cold or hot
☐ Work around noise above conversation level
☐ Work in restricted access to laboratory area
☐ Exposure to dust/gas/fumes/steam/chemicals
☐ Work with Select Agents as defined by the CDC
☐ Work irregular hours that often include nights and weekends
☐ Work in multiple locations
Minimal travel to other sites. May include international travel.
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.
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.
Job posted: 2020-07-21