Sr Manager, Regulatory Affairs - CMC - Remote
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 Snr. Manager will lead the development of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies and follow-through to implementation for assigned products/projects; this includes the management and/or authoring, and review of Module 3 CTD sections. The Snr. Manager will work with the project team to ensure consistency across product portfolios with respect to CMC taking into consideration data integrity and good documentation best practices for both commercial and developmental products. The Snr. Manager is responsible for developing and executing sound CMC filing strategies which leverage the ICH concepts, including but not limited to, scale-up and technical transfer, comparability, stability and shelf-life considerations, the quality target product profile (qTPP) and the analytical TPP (aTPP) as foundational tools in product development.
The Snr. Manager, in collaboration with the technical teams will lead agency meetings, teleconferences, and other communications related to CMC (including pre-read packages and/or other necessary documentation). The Snr. Manager will work with other team members to ensure best outcomes for CMC changes by educating teams on regulatory risks and data requirements needed for quality dossier. The Snr. Manager will utilize technical knowledge and effectively apply regulations and guidelines to ensure successful quality submission for assigned projects. This role will report to the Director, Regulatory Affairs.
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 CMC regulatory strategy, plans, regulatory expectations and data required for successful approval of regulatory submissions.
• Lead regulatory activities for global CMC submissions to gain alignment with team members, line management, and multiple stakeholders including regulatory agencies.
• Plan, coordinate, prepare and lead meetings and teleconferences with regulatory agencies on complex and strategic related CMC projects and/or programs.
• Oversee the development of innovative, risk-based, regulatory strategies for significant CMC initiatives and/or changes for Emergent products and advise on standard approaches and best practices for regulatory filings.
• Monitor and assess industry (e.g. FDA, Health Canada, EMA, WHO and ICH guidance) 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.
• Support, from a regulatory filing perspective, opportunities for harmonization and efficiency with respect to standard approaches and lifecycle management of products across the Emergent portfolio.
• Network and build professional relationships, influence and interact with internal (i.e. subject matter experts within the company) and external customers.
• Interact with company partners, consultants, and health authorities for various regulatory matters as needed.
• 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
• Prepare responses to complex questions and comments from regulatory agencies
• Provide regulatory assessment for deviations (as required), change controls and manage associated regulatory activities to ensure compliance
• Other duties as assigned.
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 8 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
• Must have experience with leading CMC submissions and authoring of Module 3 narratives.
• Must be well versed with the ICH Q8-Q12 ICH concepts and tools.
• Experience with biologics and/or vaccines is preferred.
• Ability to work on problems of diverse scope and solves with minimal assistance
• Identifies priorities and key issues in complex situations and solves with minimal assistance
• Exercises judgement within generally defined regulatory practices and policies
• Ability to guide, train, supervise and mentor personnel within the regulatory affairs team
• Effective in both written and oral communication
• Ability to anticipate and prevent potential issues
• RAC certification is preferred.
• Experienced in leading cross-functional interactions related to regulatory matters.
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.