Director, Regulatory Affairs, Pharmaceutical Products
JOB OBJECTIVE: This leadership role requires an individual to specifically have the education and experience to plan, direct, and coordinate regulatory activities to support Usona’s drug development programs. This position provides expertise to ensure compliance with federal and state regulations across all functional areas of drug development. Strong knowledge of FDA regulations and submissions is required, as well as established experience interfacing with global regulatory agencies.
1. 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).
2. 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).
3. 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.).
4. Proactively identify and address regulatory compliance issues. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
5. 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.
6. Manage a team of regulatory affairs staff to ensure the team delivers consistent and high-quality work products in a timely manner.
7. Communicate regulatory information to team members, partners, and other stakeholders and ensure that the information is interpreted and relayed correctly.
8. Attend meetings and engage with designated working teams and provide regulatory input and guidance to project teams, including quality control practices.
9. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity, and respect for others.
10. Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.
11. Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
1. Bachelor’s degree required, preferably in Regulatory Science or a health sciences field.
2. 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).
3. Strong scientific or clinical research background required.
4. 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
5. Demonstrated track record of preparing original INDs, NDAs, and amendments in compliance with applicable FDA regulations.
6. Demonstrated CMC regulatory experience with drug substance and/or drug product and API production.
7. Familiar with a variety of the field's concepts, practices, and procedures, including FDA guidance documents and ICH guidelines and GCP.
8. Ability to work in a cross-functional team environment with dynamic timelines and priorities.
9. Experience with DEA-regulated substances and clinical trials.
10. Strong knowledge of eCTD elements and format and submissions process and procedures.
11. Critical thinking/problem-solving, writing, oral communication and organizing skills and presentation skills.
12. Ability to rely on experience and judgment to plan and accomplish goals.
13. Ability to perform a variety of tasks, including conducting primary work as well as leading and directing the work of others. A wide degree of creativity and latitude is expected.
14. Experience working with all levels of management and key business stakeholders.
1. Master's degree in management of Drug Development, Regulatory Affairs, or similar field.
2. Professional certification in regulatory affairs (e.g., RAC or similar credential).
1. Ability to use a computer/Microsoft Office applications.
2. Ability to remain stationary for several hours at a time.