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, Chemistry, Manufacturing and Controls (CMC) will support regulatory activities for Emergent’s mature product portfolio and facilities and will report to the Director, Regulatory Affairs. They will act as the regulatory representative on assigned product teams and specified cross-functional project teams. They will work with functional line management and team members across multiple disciplines, in particular CMC, to develop regulatory strategies and manage regulatory submission activities. The Sr. Manager will take the lead on regulatory activities, including the management of global license maintenance activities from a CMC perspective, authoring, review, and coordination of submissions, as well as leading, planning and executing meetings with regulatory agencies. They will educate teams regarding regulatory risks and implications for strategy, product/process development, and/or post approval change activities, and utilize technical knowledge and effectively apply regulations and guidelines to the assigned projects.
• Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory CMC strategy and plans to gain alignment with team members, line management, and multiple stakeholders
• Develop innovative CMC regulatory strategies that incorporates risk identification and mitigation
• Lead the preparation, planning and execution of aligned CMC regulatory strategy through timely regulatory submissions
• Oversee development of submission content, documents and timelines for CMC filings
• 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 CMC and/or facilities 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
• Monitor industry (e.g. FDA, Health Canada, EMA, WHO and ICH guidances) landscape for pertinent and impactful guidance, policies, with focus on regulatory CMC compliance and industry best practices, apply and provide this regulatory intelligence to project teams as applicable.
• 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.
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.
• Experience in pharmaceutical development with a history in process development and/or validation preferred.
• 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
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
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.