Director, Regulatory Affairs

19 Apr, 2021

Jobs

Director, Regulatory Affairs

Emergent Biosolutions
Gaithersburg, MD

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.

The Director, Regulatory Affairs will oversee regulatory activities for assigned portfolios supporting Emergent’s Business Units and/or facilities as required. The Director Regulatory Affairs is responsible for directing the RA department in leading the development and implementation of RA strategies and establishing optimal regulatory positions for new products and existing commercial products.

 

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

Major Responsibilities and Duties

  • Directs and develops regulatory group and/or team at one or more Emergent sites
  • Oversee and lead regulatory strategy and apply global perspective on product planning.
  • Provide regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products; identify options and influence decision.
  • Directs efforts for planning and execution of required regulatory filings; oversee development of submission content and documents – provide guidance when appropriate
  • Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure approvals are obtained.
  • Plan, prepare and execute for meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies and build rapport with regulators to best position for positive outcomes.
  • Manage preparation and communicate regulatory risk assessment to core team, business unit team and senior management; propose mitigation approaches
  • Provide critical review of documentation supporting regulatory applications; analyze and resolve submission issues and identify new content as needed
  • Ensure RA activities are aligned to project timelines & business objectives and are compliant with ICH, FDA, HC, and EU regulations
  • Maintain knowledge of regulatory environment, regulations and guidance
  • Interact with company partners and consultants for various regulatory matters as needed
  • 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
  •  Identify and build external advocate network. Work with Regulatory Intel & Policy group to assess impact on new guidance & regulations.
  • Collaborate with business and technical groups on content of labelling
  • Monitor key competitor positioning and determine impact to strategy
  • Provide input into Regulatory Vision and develop operational plans
  • May be responsible for department budget

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

  • B.Sc. degree in related biological and life sciences field (M.Sc. or Ph.D. preferred)
  • 12+ years directly related experience in Regulatory Affairs, in biotechnology or pharmaceutical industry.  Less experience acceptable for suitable candidates with relevant industry experience and skill sets
  • Knowledge of global regulations / guidance 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, clinical and non-clinical pharmaceutical development,
  • Possess a broad knowledge of biopharmaceutical manufacturing and operations.
  • Demonstrated people-leader skills and evaluation of performance.

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.

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Job posted: 2021-04-19