1+ months

Sr. Specialist, Regulatory Affairs - CMC - Remote

Winnipeg, MB R3B Work Remotely


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 Sr. Specialist, Regulatory Affairs will support the development of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies and follow-through to implementation for assigned products/projects; this includes the authoring and/or review of Module 3 CTD and Module 2 sections. The Snr. Specialist 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. Specialist will support the CMC lead on 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. Specialist will support the CMC Lead with developing background packages and other documentation needed for regulatory interactions with Health Authorities. The Snr. Specialist 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. Specialist will utilize technical knowledge and effectively apply regulations and guidelines to ensure successful quality submission for assigned projects. This role will report to the Snr. Manager, Regulatory Affairs.

ESSENTIAL FUNCTIONS
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.
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 the preparation and maintenance of regulatory license applications or supplements/variations in accordance with health authority requirements and Emergent procedures.
Collaborate with cross-functional teams (e.g., manufacturing, quality, analytical, product development) to help develop regulatory strategies, as well as draft and manage regulatory submissions which help drive business objectives. Utilize regulatory technical writing skills to lead authoring of submission documents and guide team on level of detail required for the submission.
Build professional relationships, influence, and interact with internal (i.e., subject matter experts with Emergent and across Emergents product portfolio) and external (e.g., the FDA) customers while participating on teams as a Regulatory Affairs representative. Leverage relationships to bring together ideas and insights to drive continuous improvements across projects, product teams, and sites.
Participate in evaluating dossier management processes, identifying and sharing best practices with an end goal of continuous improvement and driving efficiencies. May act as SME for specific processes that support entire department.
Provide critical review of technical and scientific data to ensure regulatory compliance; begin to identify potential risks in submissions; communicate requirements, gaps, and areas of risk to project teams and line management.
Support preparation of responses to complex questions and comments from regulatory agencies as well as assist in the planning, coordination, and preparation for meetings and teleconferences with 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 managements assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
5 years of Regulatory Affairs experience preferred in pharmaceutical/biological/vaccine product development, but relevant work experience in pharmaceutical industry will be considered.
Bachelors degree in a life sciences or related discipline required.
Strong written and verbal communications.
Strong interpersonal skills and ability to build networks
Experience in document database management, electronic submissions preferred. Proficient in MS Word and other MS Office applications.
Solves routine problems with input from line management
Works within timelines and works with line management to set priorities
Basic knowledge of US, Canadian and/or EU regulations and guidelines
Basic understanding of drug development process
Familiar with quality systems (GXPs)
Experience in preparation of submissions (e.g. IND, BLA, CTA, NDS, MAA)

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.

Categories

Industry

  • Biotechnology
Posted: 2022-03-28 Expires: 2022-06-10

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Sr. Specialist, Regulatory Affairs - CMC - Remote

Emergent BioSolutions Inc.
Winnipeg, MB R3B

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