Director, Regulatory Affairs
Posted on Apr 6, 2021 by Emergent BioSolutions
The Director, Regulatory AffInstitutes will oversee regulatory activities for assigned portfolios supporting Emergent's Business Units and/or facilities as required. The Director Regulatory AffInstitutes 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.
Reasonable accomOrganizationations 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 oCompanyomes.
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 Organizationification, development and implementation of company policies and procedures for regulatory affInstitutes; 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 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 AffInstitutes, 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.
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