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Gaithersburg, Maryland Emergent BioSolutions

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, Regulatory Affairs, CDMO/Facilities will support regulatory activities related to Chemistry and Manufacturing (CMC) and Emergent Facilities across all Business Units and across all Emergent CDMO sites. The Sr. Manager will provide regulatory strategy, direction, support and advice to assigned project teams. They will lead and provide regulatory support for Emergent's Contract Development and Manufacturing Operation (CDMO) sites. The Snr. Manager will lead and support the development of sound regulatory strategies and follow-through to implementation to assigned project teams for CMC and facilities topics. The Snr. Manager will lead and support the regulatory activities related to CMC and/or facility changes, including the management of authoring, review, and coordination of quality submissions as applicable. The Snr. Manager will help prepare the team for meetings, teleconferences, and other communications (including pre-read packages and/or other necessary documentation) with FDA and other global regulatory agencies as applicable. The Snr. Manager will work with other RA team members and product leads to ensure best outcomes for CMC changes. 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.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Lead, support and advise on regulatory activities for global CMC changes.
• Serve as the regulatory lead for Emergent's CDMO sites including leading and supporting regulatory activities related to third-party drug substance and drug product manufacturing.
• Lead and liaise with Emergent's CDMO sites to ensure regulatory viability of CMC initiatives.
• Contribute to best practices for RA assessment of change controls, advise on requirements for facility and equipment changes to ensure consistency of like changes across the enterprise. Maintain learnings and information gained accordingly.
• Lead and support other CDMO activities including leading the authoring of briefing packages for facility related health authority meetings, serving as the primary regulatory point of contact for the site as needed.
• Lead the lifecycle maintenance of facilities' Type V DMFs.
• Support and provide guidance the RA Product Lead in the development of innovative, risk-based, regulatory strategies for significant CMC changes for Emergent products
• Represent RA on global project teams for CMC changes; provide guidance to project teams with respect to regulatory expectations and data requirements.
• Develop and support the RA Product Lead and/or the CDMO BU, including external stakeholders with the preparation of global CMC regulatory submissions (including meeting requests), ensuring global alignment across impacted stakeholders and jurisdictions.
• 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.
• Provide critical review, and feedback of all documentation supporting CMC regulatory documents, including but not limited to, CTD narratives, comparability protocols
• Plan, coordinate, prepare and lead meetings and teleconferences with regulatory agencies on complex and strategic related CMC projects and/or programs.
• Build professional relationships, influence and interact with internal (i.e. subject matter experts with Emergent and across Emergent's manufacturing facilities) and external (e.g. the FDA) customers.
• Work closely with Regulatory Product Leads and Regulatory Operations for timely submission of electronic and paper submissions.
• Provide regulatory review, feedback and /or approval for relevant documents.
• Interact with company partners and consultants for various regulatory matters as needed
• 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
• As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
• Interact with company partners and consultants for various regulatory matters as needed
• As required, develop procedures to support the regulatory affairs department
• 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.

• Bachelor's degree in a life sciences or related discipline required; advanced Degree (MS or PhD) preferred.
• Experience in pharmaceutical development with a history in process development/validation preferred.
• 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 agencies as required
• Experience with biologics and/or vaccines is preferred.
• Ability to work on problems of diverse scope
• RAC certification would be a plus.
• 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
• Knowledge and experience of the development of one or more types of Health Authority regulated products (drugs, biologics, medical devices, combination products)

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.

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.