Associate Director, Regulatory Affairs Advertising and Promotion
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 2353059
Job Description Summary
The Associate Director, Regulatory Affairs Advertising and Promotion will be responsible for providing strategic guidance on the development and implementation of advertising and promotional materials for pre-launch and commercial programs. This position will ensure that promotional and other product and disease-related materials are compliant with applicable regulations, guidelines, corporate polices and business objectives. This person will also ensure effective communication and constructive working relationships with regulatory authorities and internal/external collaborators. The position will report to the Director, Regulatory Affairs Advertising and Promotion.
- Provide commercial regulatory knowledge, guidance, and risk assessments to cross-functional teams developing advertising and promotional materials, as well as senior management, that are aligned with corporate commercialization efforts
- Collaborate with cross-functional teams, including field sales team, in creating and reviewing promotional materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives
- Conduct Regulatory promotional labeling and marketing compliance reviews of Clinical, Medical Affairs, Corporate Communications and Commercial materials and communications (e.g., marketing materials, disease education, institutional promotion, press releases, websites, social media, speaker presentations, talking points) to ensure promotional, scientific, medical and corporate external communications are compliant with applicable regulations, guidelines, corporate polices and business objectives
- Support the establishment of OPDP submission binder generation process to support electronic submission of materials for products approved via Accelerated Approval (21 CFR 314.550) subpart H
- Serve as an assigned contact to the US FDA Office of Prescription Drug Promotion (OPDP) and lead and prepare appropriate regulatory submissions and collaborate within Regulatory Affairs to develop and represent overall regulatory product strategy
- Ensure timely submission of promotional materials to OPDP
- Serve as a Regulatory Reviewer on the Medical, Legal, & Regulatory (MLR) review for Medical Review Team and Promotional Review Team
- Ensure that changes in product labeling are appropriately implemented and reflected in current promotional labeling and advertising
- Work collaboratively with the commercial team and any associated compliance functions to ensure that approved materials are used within the intended guidelines and duration of use
- Identify potential areas of regulatory compliance vulnerability and risk; develop/implement corrective action plans for resolution of problematic issues and provide general guidance on how to avoid or deal with similar situations in the future
- Participate in training of sales and marketing personnel on promotion, marketing, labeling and advertising regulations
- Collaborate with the team to support the ongoing improvements of the MLR review process
- Collaborate and provide input to other stakeholders to develop policies and SOPs to support the company's Commercial and Medical Affairs activities
What is Required
- 8+ years required of regulatory pharmaceutical industry experience and at least 3 years' experience in advertising and promotion regulatory affairs including participation on MLRs, or equivalent experience, labeling development/maintenance experience is a plus
- BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred
- Outstanding interpersonal, written, and verbal communication skills
- Attention to detail and highly organized
- Solid understanding of regulatory requirements for compliant advertising and promotional materials
- History of providing creative solutions to Commercial and Medical Affairs teams exhibiting superior judgment and a balanced, realistic understanding of issues
- Fluency in English as business language
- US regulatory experience required; Ex-US regulatory experience is a plus
- Familiarity with Veeva PromoMats, Veeva MedComms, and Veeva RIMS a plus
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.