23 days old

Manager, Regulatory Affairs

Emergent BioSolutions Inc.
Canton, MA 02021


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 Regulatory Affairs Manager will support regulatory activities for Vaccines Business Unit as the regulatory representative on assigned Product Team(s).  He/she will work with functional line management and team members across multiple disciplines including nonclinical, clinical and CMC to develop regulatory strategies and manage regulatory submission activities. The RA manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as planning and executing meetings with regulatory agencies.

 

Essential Functions   
    Represent Regulatory Affairs as the SME on assigned product/ project teams and ensure timely communication of regulatory strategy and plans to team members and line management
    Develop regulatory strategy for assigned products and/or country
    Plan and coordinate the preparation of regulatory submissions including meetings with health authorities and routine correspondence
    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
    Plan, coordinate, prepare and support meetings and teleconferences with regulatory agencies and submission meetings; may also be required to work with government funding agencies
    Prepare responses to complex questions and comments from regulatory agencies
    Ensure regulatory product compliance for product (e.g. agency commitments)
    As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
    Conduct and analyze regulatory research to understand competitor activity 
    Interact with company partners and consultants for various regulatory matters as needed
    As required, develop procedures to support the regulatory affairs department
    Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to assigned programs. Interpret existing regulations and guidance documents for regulatory department and/or project teams
    May be responsible for a functional area and/or have direct reports


The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

Minimum Education, Experience, Skills
    Bachelors degree in a life sciences or related discipline required.  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
    Ability to work on problems of diverse scope
    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
    Thorough knowledge of the development of one or more types of Health Authority regulated products (drugs, biologics, medical devices, combination products)
    Ability to anticipate and prevent potential issues
    Understanding of regulatory issues and their touch points 

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

Posted: 2020-12-31 Expires: 2021-02-07

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Manager, Regulatory Affairs

Emergent BioSolutions Inc.
Canton, MA 02021

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