Director, Regulatory Operations
Director, Regulatory Operations
Posted Nov 12, 2019
Job Title: Director, Regulatory Operations
Location(s): Boston, MA
Posted Nov 12, 2019
Job Title: Director, Regulatory Operations
Location(s): Boston, MA
Company Overview
Cerevel Therapeutics is a new biopharmaceutical company formed by Bain Capital and Pfizer that relentlessly finds paths through complexity to bring real progress and new treatment options to people living with neurological and neuropsychiatric disorders.
Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders including Parkinson’s, Alzheimer’s, epilepsy, schizophrenia and addiction.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.
Cerevel aspires to develop and nurture a culture characterized by respect, trust, curiosity, compassion with a relentless focus on mission and results. Our patient- centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring his/her own unique thinking and approach to Cerevel while sharing our core values and convictions.
Company Overview
Cerevel Therapeutics is a new biopharmaceutical company formed by Bain Capital and Pfizer that relentlessly finds paths through complexity to bring real progress and new treatment options to people living with neurological and neuropsychiatric disorders.
Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders including Parkinson’s, Alzheimer’s, epilepsy, schizophrenia and addiction.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.
Cerevel aspires to develop and nurture a culture characterized by respect, trust, curiosity, compassion with a relentless focus on mission and results. Our patient- centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring his/her own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role Summary
Reporting to the Vice President, Head of Global Regulatory Science, this key position leads and provides an oversight of all regulatory operations activities. Primary duties involve establishment of departmental processes and procedures, vendor selection, management, implementation and maintenance of publishing tools and systems. It is the responsibility of the Head of Regulatory Operations to ensure that the current regulations and document standards, are adhered to and the document processing activities associated with generating regulatory submissions are performed in accordance with global regulatory guidelines. The Head of Regulatory Operations serves as liaison with functional group representatives, managers functional service provider as well as outside vendors and other service providers.
Key Responsibilities
- Responsible for managing all regulatory submissions, including the compilation, preparation, review and submission to Regulatory Agencies/Health Authorities in compliance with applicable regulations and guidelines
- As subject matter expert, assures completeness and quality of documents and submissions from the Regulatory Operations perspective
- Manage electronic submission publishing activities with third-party vendors
- Manages the coordination of regulatory document routing, revision tracking, and document approvals
- Participates in the evaluation, selection, validation (as applicable) and implementation of technology and equipment related to submission planning, preparation, assembly, dispatch, and/or archiving
- Create and manage submission plans in conjunction with Regulatory colleagues
- Represents Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities
- Creates, updates and maintains submission templates as needed
- Writes and reviews internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation, QC, and records management
- Develops proposals for continuous improvement of internal systems and processes related to publication, submissions, and archiving of regulatory dossiers
- Monitors impact of changing regulations on e-submission requirements and updates internal stakeholders
- Independently identifies compliance risks related to Regulatory Operations and escalates when necessary
- Oversee the management of Regulatory records and databases
Required Qualifications
- Minimum of 8 years of relevant experience in a Regulatory Operations or related role
- Strong knowledge of Agency regulations, industry standards, and CTD/eCTD requirements pertaining to regulatory operations is essential.
- Strong understanding of the drug development process.
- Regulatory submissions experience, specifically experience with eCTD format submissions for INDs and/or NDAs.
- In-depth experience in document management and Regulatory publishing.
- Excellent verbal, written, strong organizational and time management skills and ability to think strategically.
- Must have a strong attention to detail and skill in compiling/reviewing submission documents to ensure compliance with regulatory publishing standards.
- Extremely proficient with publishing tools/eCTD software, EDMS, MS Word, Word templates, Adobe Acrobat and standard Office tools.
- Ability to work independently with little supervision
- Must be able to work effectively within an environment that has quickly changing processes, priorities, and deadlines.
Desired Qualifications
- Experience with Veeva is a plus
- Experience communicating with regulatory agencies a plus
Education
- BA/BS degree in science or health related field, with advanced degree preferable
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
© 2019 Cerevel Therapeutics, LLC.
CEREVEL and the CEREVEL logo are trademarks of Cerevel Therapeutics, LLC. All Rights Reserved.