Job ID: 7576
Job Title: Director Regulatory Affairs
Location: Greater Philadelphia, PA
Location: (Hybrid) Greater Philedelphia, PA (or) Boston, MA Position
Our client is a commercial-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH). They are focused on addressing significant unmet medical needs and are at the forefront of developing breakthrough solutions. With a collaborative culture and a commitment to scientific excellence, our client empowers its employees to contribute meaningfully to life-changing advancements in healthcare.
Position: The Director of Regulatory Affairs will manage the day-to-day regulatory activities of assigned projects for compounds under development and/or marketed. These activities include acting as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities.
Responsibilities:
- Actively participates on Project Teams in developing, creating, and implementing regulatory and development products by providing regulatory guidance and compliance oversight for regulated products.
- Works collaboratively with Project Teams to develop draft labeling for drug development candidates. Participates in cross-functional teams to establish a regulatory strategy for developing content for draft package inserts for NDA submissions.
- Interfaces with various departments within R&D, Commercial, and other applicable groups to develop and execute viable Regulatory Strategies. Demonstrate leadership in developing partnerships both internal and external to the company. Accurately assess and convey regulatory risk/opportunities and influence decision-makers.
- Managed the compilation, submission, and maintenance of INDs, NDAs, MAAs, CTAs, amendments, and supplements.
- Support and participate in the Company’s due diligence activities, which evaluate potential products for acquisition/in-licensing/joint development opportunities.
- Facilitates the regulatory strategy and serves as a Company contact with FDA and ex-US regulatory agencies.
- Liaise with the FDA review divisions and represent Regulatory at FDA meetings (e.g. pre-IND, EOP2, Pre-NDA) and with global health authorities and development partners as appropriate for their projects.
- Leads the preparation for meetings conducted with CDER, including rehearsals and development of meeting requests and briefing books.
- Monitors the regulatory environment and communicates developments to various company stakeholders (clinical, regulatory, senior leadership, etc.).
- Applies strong technical, regulatory knowledge to advising business functions regarding regulatory requirements to enable the successful implementation of business strategies.
Qualifications:
- A BS in life sciences in a healthcare field or equivalent experience with an advanced degree is strongly preferred.
- Minimum 10 years of branded regulatory pharmaceutical drug development experience.
- Broad-based therapeutic area and product experience.
- Strategic regulatory affairs experience with a proven track record in new chemical entity and line extension regulatory filings, approvals, and strategic planning.
- Demonstrated experience supporting and conducting due diligence activities.
- Demonstrated experience interacting with global health authorities.
- Strong knowledge of regulations/guidelines governing the global development of pharmaceuticals is required.
- Excellent communication skills and proven negotiation skills. Must be able to effectively communicate with scientists at all levels and be able to present a scientific case to communicate within the organization and/or regulatory agencies effectively
