Do you have strong Regulatory experience in pharmaceutical drug development and a passion for mental health treatment? This could be the perfect leadership role in the next step of your career!
What You'll Do:
The Director, Regulatory Affairs is responsible for the strategic planning, direction and coordination of regulatory activities to support the company's leading drug development programs. This individual will be the key leader in providing expertise to ensure compliance with federal and state regulations across all functional areas of drug development. In addition to a strong knowledge of FDA regulations and submissions, as well as significant experience working with global regulatory agencies, key responsibilities of the role include: Apply strategic knowledge to small molecule drug development across all stages of a product’s lifecycle (pre-IND through post-licensure) and across functional disciplines (e.g., clinical, nonclinical pharmacology/toxicology, clinical pharmacology, CMC).
Skillfully lead communications with FDA and other global regulatory agencies (e.g., formal meetings, emails, etc.) to facilitate review and approval of submissions (including INDs and NDAs).
Develop, review, submit and follow all regulatory agency submission materials (e.g., initial IND applications, annual reports, clinical study reports, protocols, and amendments, MedWatch reports, etc.).
Proactively identify and address regulatory compliance issues. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Lead, develop, and implement CMC regulatory strategies to ensure on-time and high-quality submissions for Drug Master Files (DMFs), marketing applications (NDA/ANDA), and post-approval lifecycle submissions. Serve as main contact with regulatory agencies (e.g., FDA, DEA, EMA health authorities, state authorities, etc.) when needed for drug product development.
Manage a team of regulatory affairs staff to ensure the team delivers consistent and high-quality work products in a timely manner.
Communicate regulatory information to team members, partners, and other stakeholders and ensure that the information is interpreted and relayed correctly.
Attend meetings and engage with designated working teams and provide regulatory input and guidance to project teams, including quality control practices.
Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Act with kindness, curiosity, and respect for others.
Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
What You'll Bring:
Bachelor’s degree required, preferably in Regulatory Science or a health sciences field. Master's Degree ideal.
A minimum of fifteen years of experience in the pharmaceutical industry (small molecule) or a related area. (Proven 5 years in a senior leadership role with strong management skills).
Strong scientific or clinical research background required.
Demonstrated knowledge of regulatory affairs, such as 21 CFR 210/211/310/312/314, FDA guidance documents, and ICH guidelines for both development projects and commercial projects, with evidence of successful submissions to FDA, EMA, MHRA, or other health authorities
Demonstrated track record of preparing original INDs, NDAs, and amendments in compliance with applicable FDA regulations.
Demonstrated CMC regulatory experience with drug substance and/or drug product and API production.
Familiar with a variety of the field's concepts, practices, and procedures, including FDA guidance documents and ICH guidelines and GCP.
Ability to work in a cross-functional team environment with dynamic timelines and priorities.
Experience with DEA-regulated substances and clinical trials.
Strong knowledge of eCTD elements and format and submissions process and procedures.
Critical thinking/problem-solving, writing, oral communication and organizing skills and presentation skills.
Experience working with all levels of management and key business stakeholders.
Familiarity or experience with regulations related to controlled substances is ideal, but not required.
Apply Now and move your career forward with a great team and non-profit leader in mental health! Questions? Contact Andie Veach directly at Andie@CarexScientific.com
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
