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Sr. Specialist, Regulatory Affairs

Location: 

Gaithersburg, MD, US, 20879


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. Specialist, Regulatory Affairs will support regulatory activities related to Chemistry and Manufacturing (CMC) and Emergent Facilities changes across all Business Units and report to the Snr. Manager, Regulatory Affairs.  They will provide regulatory assistance for Emergent’s Contract Development and Manufacturing Operation (CDMO) sites. The Snr. Specialist will work with the Snr. Manager to support the development of sound regulatory strategies and follow-through to implementation to assigned project teams for CMC and facilities topics. The Snr. Specialist will support the regulatory activities related to CMC and/or facility changes, including providing assistance on management of authoring, review, and coordination of quality submissions as applicable. The Snr. Specialist 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. In conjunction with the Snr. Manager, the Snr. Specialist will work with other RA team members and product leads to ensure best outcomes for CMC changes.  They will help 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 as applicable. 

 

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

•    Support and advise on regulatory activities for global CMC changes.
•    Liaise with Emergent’s CDMO sites and support the Snr. Manager, RA, to ensure regulatory viability of CMC initiatives.
•    Support and provide guidance to 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.
•    Help develop and support the RA Product Lead and/or the CDMO BU 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.
•    Support the Snr. Manager to provide critical review, and feedback of all documentation supporting CMC regulatory documents, including but not limited to, CTD narratives, comparability protocols 
•    Coordinate and support the planning, and preparation of 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
•    Support in providing gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management
•    Support preparation of  responses to complex questions and comments from regulatory agencies
•    As required, provide support for regulatory assessment for deviations, change controls and associated regulatory activities to ensure compliance
•    Interact with company partners and consultants for various regulatory matters as needed
•    As required, assist in developing 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. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor’s degree in a life sciences or related discipline required. 
•    Experience in pharmaceutical development with a history in process development/validation preferred.
•    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 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)

 

 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.
 

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.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.