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 Senior Director, Regulatory Affairs, will oversee regulatory activities for Emergents applicable Business Units and/or Functional Area. The Senior Director Regulatory Affairs is responsible for providing the strategic direction to the RA department and/or global RA team, as well as building and maintaining high performing RA professionals. He is responsible to develop regulatory strategies and tomanage the regulatory process fromdevelopment and approval through to life-cycle. He ensures compliance with regulatory requirements.
- Directs a team of regulatory professionals located across Emergent sites, responsible for performance and talent management.
- Represents Regulatory Affairs on the business unit leadership team and/or assigned enterprise cross-functional teams.
- Leads and oversees strategies with a broader Business Unit/Global RA view and supports alignment of business unit and RA priorities influences decision-making on new product development as well as resource and budget allocation.
- Provides regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical testing for products.
- Directs efforts for managing multiple large-scale submissions
- Ensures oversight and manages RA department interface with regulatory authorities in an optimal manner; negotiates controversial issues with regulatory bodies.
- Manages preparation and communicates regulatory risk assessment to business unit team and senior management and proposes mitigation approaches.
- Maintain knowledge of regulatory environment, regulations and guidances.
- Contributes to the modification, development and implementation of company policies and procedures for regulatory affairs with a global, cross-business unit view.
- Writing/reviewing regulatory/scientific submissions.Negotiating scientific data and plans with regulatory authorities.
- All regulatory actions for Vivotif and other products. Site specifc authority interactions.
- Being the key contact person for R&D, marketing, quality, production, company subsidiaries and partner companies for regulatory matters regarding the designated RA area.
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.
Education, Experience & skills
- B.Sc. degree in a life sciences field or related discipline required (MS or PhD preferred)
- Approximately 15+ years of relevant pharmaceutical industry experience, with at a minimum of 10+ years directly in Regulatory Affairs. Less experience acceptable for suitable candidates with relevant industry experience and skill sets.
- Knowledge of global regulations / guidances and thorough knowledge of biological/drug development process required.
- Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communication skills
- Strong decision-making abilities
- Demonstrated leadership capabilities, including performance management, conflict resolution, developing talent and proven ability to build effective teams.
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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.