Sr Manager, Regulatory Affairs

Location
Lansing, MI, US
Posted
Oct 15, 2020
Ref
655063000
Required Education
Bachelors Degree
Position Type
Full time
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 Senior Manager, Regulatory Affairs will support regulatory activities for the vaccines portfolio as the regulatory representative on assigned Product/Project 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 Sr. Manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as leading, planning and executing meetings with regulatory agencies.

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 regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders
  • Develop innovative regulatory strategies that incorporates risk identification and mitigation
  • Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions
  • Oversee development of submission content, documents and timelines
  • 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
  • Lead meetings both in-person and teleconferences with regulatory agencies for specific projects; may also be required to work with government funding agencies
  • Negotiate complex issues with regulatory agencies and prepare responses to questions and comments from regulatory agencies
  • Ensure regulatory product compliance for assigned products (e.g. agency commitments)
  • As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
  • 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. 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
  • May provide input to business unit strategies from regulatory perspective
  • May be responsible for a functional area and/or have direct reports

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. Approximately 10+ 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 regulatory agencies; Interactions with HSA or TGA is desired.
  • • 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


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • 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.


Travel:

Minimal travel to other sites. May include international travel.

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.