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Director, Regulatory Affairs

Employer
Emergent BioSolutions Inc.
Location
Montgomery Village, Maryland, US
Salary
Competitive
Closing date
Jan 15, 2022

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Energy
Salary Type
Salary
Employment Type
Full time
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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.

JOB SUMMARY
The Director, Regulatory Affairs (RA) will oversee regulatory activities related to Chemistry Manufacturing and Controls (CMC) and Emergent Facilities across all Business Units. They will oversee regulatory team members that serve as the regulatory representative for Emergents GMP Contract Development and Manufacturing Operation (CDMO) sites. The Director will oversee the development of a sound regulatory strategy and follow-through to implementation to assigned project teams for CMC and Facility changes. The Director will lead a team of people to work with other RA team members and product leads to ensure best outcomes for CMC and Facility changes. The Director will oversee regulatory activities related to CMC and/or facility changes, including the management of authoring, review, and coordination of a quality submissions as applicable. The Director will oversee the preparation of team members for meetings, teleconferences, and other communications (including pre-read packages and/or other necessary documentation) with FDA and other global regulatory agencies as applicable. They will ensure the training and education of the RA team 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.

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

Major Responsibilities and Duties:
Oversee regulatory activities for global CMC Facility changes.
Oversee and liaise with Emergents CDMO sites and ensure regulatory viability of CMC initiatives.
Oversee and/or support the RA Product Lead in the development of innovative, risk-based, regulatory strategies for significant CMC changes for Emergent products manufactured within the Emergent CDMO enterprise
Represent and/or oversee RA membership on global project teams for CMC Facility changes; provide guidance to project teams with respect to regulatory expectations and data requirements.
Oversee and/or support the RA Product Lead with the preparation of global CMC regulatory submissions (including meeting requests), ensuring global alignment across impacted stakeholders and jurisdictions.
Monitor and participate in influencing industry initiatives related to 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/post approval change management protocols
Oversee the planning, coordination, preparation and leading of meetings and teleconferences with regulatory agencies on complex and strategic related CMC, facilities projects and/or programs.
Build professional relationships, influence and interact with internal (i.e. subject matter experts with Emergent and across Emergents manufacturing facilities) and external (e.g. the FDA) customers and CDMO clients.
Contribute regulatory perspective as needed on government proposals and external due diligence activities
Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs; maintain currency and compliance with regulatory systems and understands external trends
Provide input into Regulatory Vision and develop operational plans
Responsible for department budget and forecasting labour estimates
Provide regulatory review, feedback and /or approval for relevant documents.
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 managements assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelors degree in a life sciences or related discipline required; advanced Degree (MS or PhD) preferred.
12+ years of industry experience in Regulatory Affairs.
Must have previous experience interacting with FDA and other regulatory agencies.
Must have pharmaceutical product development experience within Regulatory Affairs. Experience with biologics and/or vaccines is preferred.
Demonstrated experience in preparing global regulatory CMC strategy for late-stage development products, including BLAs and MAAs and post-approval CMC changes for commercial products.
Experienced in vaccine product development
Knowledge of global regulations / guidances and thorough knowledge of biological/ drug development process required.
Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.
Strong decision-making abilities
Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC.
Possess a broad knowledge of biopharmaceutical manufacturing and operations.
Demonstrated people-leader skills and evaluation of performance.
Experience with having previously managed a team of individuals is an asset.

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.

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe 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.
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