Regulatory Affairs Director or Associate Director

Dennis Partners; Philadelphia (Philadelphia County); Hybrid; USD 175,000 - 240,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Director or Associate Director to lead regulatory strategy and execution for innovative therapeutics. This role involves collaborating with various departments, managing regulatory submissions, and interfacing with health authorities. With a strong cash position and an approved product, this is an exciting opportunity to join a rapidly growing organization that values a patient-focused culture and offers hybrid working arrangements. If you are passionate about regulatory affairs and want to make a significant impact in a dynamic environment, this position is for you.

Benefits

Annual Target Bonus

Equity

Comprehensive Benefits

Qualifications

• 8+ years of experience in Regulatory Affairs for pharmaceutical drugs.
• Strong knowledge of regulations governing global pharmaceutical development.

Responsibilities

• Develop and execute regulatory strategies for clinical and commercial programs.
• Liaise with FDA and manage regulatory submissions for drug development.

Skills

Regulatory Strategy Development

Interpersonal Skills

Conflict Management

Negotiation Skills

Technical Regulatory Knowledge

Communication Skills

Education

Bachelor's Degree in a Scientific Discipline

Advanced Degree (MS, PharmD, or PhD)

Job description

This company is developing and commercializing novel therapeutics for the treatment of nonalcoholic steatohepatitis (NASH). They are seeking a Regulatory Affairs Director or Associate Director who can contribute to Regulatory strategy and execution for their commercial and clinical programs. Reporting into the SVP of Regulatory, you will act as the Regulatory representative on core teams and liaise with health authorities. This company offers a collaborative, patient-focused culture and hybrid working arrangements. With one approved product and a strong cash position, now is an exciting time to join this rapidly growing organization.

Responsibilities:

• Interface with various departments within R&D, Commercial and other applicable groups to develop and execute viable Regulatory Strategies.
• Manage the day-to-day regulatory activities of assigned projects for compounds under development and/or marketed products.
• Develop and plan regulatory submission strategies, and coordinate the preparation of submissions to regulatory agencies.
• Serve as a company contact with FDA and ex-US regulatory agencies.
• Responsible for managing the compilation, submission and maintenance of INDs, NDAs, MAAs, CTAs, amendments, and supplements.
• Act as the regulatory representative on core teams. Actively participate on Project Teams in the development, creation, and implementation of regulatory strategies by providing regulatory guidance and compliance oversight for regulated products.
• Liaise with the FDA review divisions and represent Regulatory at FDA meetings (e.g. pre-IND, EOP2, Pre-NDA).
• Lead the preparation for meetings conducted with CDER, including rehearsals and development of meeting requests and briefing books.
• Demonstrate leadership in developing partnerships both internal and external to the company.
• Accurately assess and convey regulatory risk/opportunities and influence decision makers.
• Work collaboratively with Project Teams in the development of draft labeling for drug development candidates. Participate on cross-functional teams to establish regulatory strategy for developing content for draft package inserts for NDA submissions.
• Support and participate in the Company’s due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.
• Monitor the regulatory environment and communicate developments to various stakeholders within the company (clinical, regulatory, senior leadership, etc).
• Apply strong technical regulatory knowledge to advising business functions regarding regulatory requirements to enable successful implementation of business strategies.
• Provide expert leadership, advice, and direction regarding scientific and medical issues as related to application of the FDA and other regulatory requirements for regulated products.
• Perform other duties as required, interfacing with other departments, CROs and external vendors as needed.

Qualifications:

• Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
• Eight or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologic therapeutics.
• Broad based therapeutic area and product experience preferred.
• Strategic regulatory affairs experience with a proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.
• Experience in designing, writing, and submission of regulatory filings (INDs, NDAs/BLAs, etc).
• Demonstrated experience interacting with FDA and global health authorities.
• Must have experience preparing for and participating in Health Authority meetings.
• Strong knowledge of regulations/guidelines governing global development of pharmaceuticals is required.
• Demonstrated experience supporting and conducting due diligence activities.
• Strong interpersonal skills, including conflict management and negotiation skills.
• Excellent oral and written communications skills. Must be able to effectively communicate with scientists at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies.
• Willing to roll up sleeves and do whatever is needed to ensure Regulatory success.
• Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.

This is a hybrid on-site position in the Greater Philadelphia area. Must be on-site three days a week.

The budgeted salary range for this position is US$175,000 to $240,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of remuneration.