The Head of Regulatory Affairs works within the Operations Team with a focus on leading corporate regulatory strategies as well as executing tactical regulatory functions. Specific job functions include regulatory support of the development and registration of the company’s products, drafting and submission of regulatory documents, license renewals, periodic updates and registrations to regulatory agencies. This role will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. Externally, the Head of Regulatory Affairs will interface with regulatory agencies, corporate partners, consultants and vendors with regards to development, regulatory and registration strategies.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
- Actively contributes to the development and implementation of regulatory strategy.
- Interacts with internal and external stakeholders, including FDA and other external regulatory and quality agencies, to collect and share information.
- Compiles, prepares, critically reviews and submits IND and BLA submissions and amendments to FDA, with an overall objective to receive approval within the shortest time frames possible.
- Submits controlled correspondence to FDA on specific issues as needed for assigned projects.
- Requests and manages meetings with FDA (e.g. pre-IND, EOPII)
- Coordinates with internal departments and CRO partners for preparation of required documents (e.g. Investigator Brochures, Informed Consent forms) and manages submissions to IRB’s.
- Maintains full awareness of all regulatory activities on assigned projects.
- Monitors impact of changing regulations on submission strategies and updates internal stakeholders accordingly.
- Works with QA on Quality Systems.
- Independently applies the appropriate regulatory guidance or guideline documents and regulations to judge the appropriateness of solutions.
- Takes responsibility and makes logical decisions for the department, and company, in compliance with regulations, by consulting and considering input from all stakeholders.
- Identifies and uses appropriate methods to collect the needed information to allow analysis and reach conclusions.
- Shows good judgment to determine when to escalate problems to his/her supervisor.
Skills, Knowledge, and Abilities Required
- Track record in working successfully on IND and BLA applications to the FDA and more than 5-8 years of regulatory affairs experience.
- Ability to create and maintain product EU technical files.
- Proven experience in authoring or assembling and submitting technical files/regulatory dossiers to the regulatory agencies such as the FDA, including familiarity and experience with the eCTD format and eSubmissions via the FDA regulatory gateway.
- Ability to communicate effectively both verbally and in writing.
- Strong business acumen and demonstrated ability to make sound decisions that contribute positively to the business.
- Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure and acting with integrity and credibility to build trust.
- Master Degree (MS/MA) of Science, Technical or more advanced degree. Ph.D. is highly preferred.
- Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must.
- Working knowledge and experience with 21 CFR, cGCPs, cGLPs, and cGMPs.
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
- Technical writing proficiency and proofreading abilities.
Precision BioSciences, Inc. is dedicated to improving life by developing advanced tools to edit DNA with a uniquely specific approach. Our proprietary method relies on a single small enzyme, ARC Nuclease, which combines cutting with sequence recognition and can be redesigned to find and edit new target sites across the genome. This simple, powerful gene editing solution allows us to create products that solve – not just treat, but solve – significant problems in oncology, genetic disease, agriculture, and beyond. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented, committed people who are excited to be a part of the medical and scientific breakthroughs enabled by Precision’s next generation gene editing technology. For additional information, please visit www. precisionbiosciences.com
Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.