CantonRecruiter Since 2001
the smart solution for Canton jobs

Manager, Regulatory Affairs

Company: Emergent BioSolutions Inc
Location: Canton
Posted on: April 2, 2021

Job Description:

By clicking the Accept button, you agree to us doing so.
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
--- Bachelor's 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 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.

Keywords: Emergent BioSolutions Inc, Canton , Manager, Regulatory Affairs, Executive , Canton, Michigan

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Shift Manager
Description: A McDonald's Shift Manager is a member of the management team. You represent McDonald's, serve customers,
Company: McDonald's
Location: Detroit
Posted on: 04/15/2021

Branch Manager
Description: Responsible for leading, managing and coaching a team of sales and service professionals to meet and exceed sales goals, ensure the operational excellence of the branch and create an excellent customer (more...)
Company: Flagstar Bank
Location: Sterling Heights
Posted on: 04/15/2021

Assistant Director
Description: Assistant Director - W Description KinderCare Education is the nation's leader in early childhood education. We nourish curiosity through purposeful experiences to create a future full of lifelong (more...)
Company: KinderCare Education
Location: White Lake
Posted on: 04/15/2021


Assistant Manager
Description: Job DescriptionABOUT THE JOB You want to be the boss Well now's your chance - Domino's Pizza is hiring bosses - more specifically assistant managers. It's a tough job, one that needs a natural like you. (more...)
Company: Domino's Pizza - 1139
Location: Eastpointe
Posted on: 04/15/2021

Salon Manager - Plymouth Road Plaza
Description: Salon Manager Got shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: West Bloomfield
Posted on: 04/15/2021

Director of Product Marketing
Description: A lot of companies say they're mission-driven . Our unique corporate structure guarantees that every decision we make upholds our mission: to make sure the internet stays available, safe, and welcoming (more...)
Company: Mozilla
Location: Detroit
Posted on: 04/15/2021

Clinical Case Manager
Description: GENERAL STATEMENT OF RESPONSIBILITIES: The Case Manager is responsible for the management of youth treatment services and youth case management services, works with the Court and may attend Court hearings. (more...)
Company: SPECTRUM JUVENILE JUSTICE SERVICES
Location: Highland Park
Posted on: 04/15/2021

Director of Recipient Rights
Description: Under the direction of the CEO, the Recipient Rights Officer will assure the agency operates a Recipient Rights system that is in compliance with the Michigan Mental Health Code P.A. 258
Company: Acadia Healthcare- StoneCrest Center
Location: Detroit
Posted on: 04/15/2021

Business Development Manager
Description: Alliance Franchise Brands LLC and its subsidiary, KK Printing Canada ULC, are the franchisors of more than 600 locations in North America operating the company's brands: Allegra Marketing Print Mail, (more...)
Company: Alliance Franchise Brands
Location: Plymouth
Posted on: 04/15/2021

Chief Operating Officer - Orchards Children's Services
Description: Our client, Orchards Children's Services, seeks an exceptional, talented individual to help its staff continue to strive to carry out its mission-strengthening the community through quality services to (more...)
Company: Apparatus Solutions, Inc.
Location: Detroit
Posted on: 04/15/2021

Log In or Create An Account

Get the latest Michigan jobs by following @recnetMI on Twitter!

Canton RSS job feeds