Director, Regulatory Affairs
Location: Boston, Massachusetts US
Job Id: 2678
Position Title: Director, Regulatory Affairs
Does driving innovative regulatory strategy get your adrenaline going? Are you highly knowledgeable on global regulatory standards? We are looking for high-energy, dedicated team members who enjoy a challenge, thrive in dynamic environments. If you are no stranger to taking charge and collaborating to deliver extraordinary work, we have an opportunity for you as a Director of Regulatory Affairs.
Why should you considering joining us? Because Precision for Medicine, Oncology & Rare Disease is not your typical CRO. By becoming a member of our growing team, you will be embarking on an opportunity to work with leading drug development experts with a niche precision medicine company. We stand out from the crowd with an unusual value proposition. We incorporate the use of biomarkers essential to targeting patients more precisely and effectively. We are not a behemoth sized CRO, which affords you the opportunity to have a voice that is heard and the ability to truly make an impact on drug development. Enough about us, let's talk about you for a while.
- You are deeply client focused and solutions oriented – always thinking of the client’s needs and compound development first
- You have a firm comprehension and understanding of the regulatory environment and can comprehend the scientific nuances that drive evolution of novel therapies
- You demonstrate flexibility by modifying your approach to tasks based on the preferences of partners and the unusual demands of each situation
- You listen attentively to what is being said and listen to understand
- You stay focused in handling multiple priorities in a dynamic environment
- You are a strategic thinker, always going beyond looking at what is and envisioning what could be
About the role:
Regulatory leadership, experience, and expertise is needed to support the advancement of new therapies. You will lead teams by providing regulatory strategy and support to for both US and international regulatory submissions. You will provide leadership for major filing activities, Health Authority interaction and meetings, and provide regulatory support. You will craft and execute global regulatory development strategies for early and late stage clinical compounds. You will:
- Serve as the representative regulatory affairs SME at project team meetings and head regulatory workflow between departments.
- Lead and facilitate the development of Health Authority meeting requests and briefing packages in preparation for meetings.
- Lead, coordinate, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports).
- Take charge of development of dossier filing plan and associated timelines with regulatory operations lead.
- Provide oversight to filing and study teams regarding regulations/ guidelines and company SOPs to ensure successful and high quality regulatory applications.
- Manage and facilitate team preparation for FDA and other Health Authority meetings.
- Drive and coordinate USPI labeling activities with cross functional team for planned regulatory filings.
- Supervise Regulatory Associate, Managers, and contract employees.
- Provide ICH/GCP/Regulation guidance, advice, and training to internal and external clients.
- Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline.
- 10 + years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience and extensive knowledge of all aspects of the drug development process.
- Experience leading/managing INDs/NDA/sNDA and/or BLA/sBLA filings in an eCTD format.
- Experience interacting and negotiating with regulators (FDA, EMA, MHRA, etc.).
- Experience with MAAs a plus.
- Experience working within a regulated industry covered by GCP/ICH guidelines and applicable Federal Regulations supporting pharmaceutical development.
- Ability to drive and availability for domestic and international travel including overnight stays.
- Advanced degree in medical or life sciences (MS, MD, PhD, PharmD) preferred.
- Experience working in hematology/oncology/rare disease.
- Experience working in a CRO.
- RAC certification or Masters in regulatory sciences.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2018 Precision Medicine Group, LLC
Division: Precision For Medicine
Business Unit: Clinical Solutions
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: Yes
Country: United States
Community / Marketing Title: Director, Regulatory Affairs
Country: United States
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
Location_formattedLocationLong: Boston, Massachusetts US