Manager, Regulatory Affairs – Combination Device Products
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 Regulatory Affairs Manager will support regulatory activities for drug-device combination products as the regulatory representative on assigned Product 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 RA manager 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.
Reasonable accommodations will be made to enable individuals with disabilities to perform the 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)
• As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
• 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
• 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
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 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 FDA,EMA, Health Canada and/or other regulatory agencies as required.
• Must have regulatory experience in submission of applications for small molecules and/or generics (additional combination product experience preferred) in an early stage and late stage development setting
• 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
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable 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.
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Job posted: 2021-11-15