Associate Director, Regulatory Affairs Advertising and Promotion

Regulatory Toolkit; Foster City (CA); Ibrido; USD 205.000 - 225.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work model

Descrizione del lavoro

Mirum Pharmaceuticals is seeking an Associate Director, Regulatory Affairs Advertising and Promotion to lead regulatory guidance for commercial materials and support FDA submissions. You will partner with the MLR team to shape strategies, timelines and cross-functional review across departments.

In this role, you will oversee submissions for promotional materials, stay current on FDA OPDP guidance, and help evolve regulatory advertising processes.

Competenze

• Bachelor’s or advanced degree in a scientific discipline with 8+ years in Regulatory Affairs.
• Minimum 6 years of regulatory review experience for advertising and promotional materials for prescription drug/biologic products.
• Experience representing Commercial Regulatory Affairs on cross-functional teams desirable.
• Excellent planning, organizational, and communication skills.

Mansioni

• Provide commercial regulatory oversight for assigned programs.
• Manage and author commercial regulatory submissions with the Publishing vendor to ensure timely publishing and submission of promotional materials to the OPDP.
• Provide regulatory guidance on new concepts and campaigns.
• Maintain awareness of FDA regulations, guidance documents, and enforcement actions for advertising and promotion of pharmaceutical products.
• Serve as a resource for commercial regulatory advice across departments.
• Contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.
• Aid in developing and implementing regulatory advertising and promotional processes.

Conoscenze

OPDP submissions experience

Regulatory advertising & promotion

Cross-functional collaboration

Written and verbal communication

Project management

Formazione

Bachelor's degree in a scientific discipline

Descrizione del lavoro

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARY

The Associate Director, Regulatory Affairs Advertising and Promotion provides regulatory guidance on commercial regulatory activities to enable the business to meet its commercial needs in a compliant manner. This position will provide regulatory guidance as a member of the Medical, Legal and Regulatory (MLR). This role is accountable for helping develop strategies and timelines, and managing internal team discussions to support preparation of advertising and promotional materials for regulatory submissions. This role will report to the Director, Global Regulatory Affairs Advertising and Promotion.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for providing commercial regulatory oversight for assigned programs.
• Manage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
• Provide regulatory guidance on new concepts and new campaigns.
• Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Help monitor enforcement trends and provide timely advice to the team.
• Recognized as a resource for commercial regulatory advice across departments.
• May contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.
• Aid in the development and implementation of regulatory advertising and promotional processes, as necessary.

QUALIFICATIONS

Education /Experience:

• Bachelor’s or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products.
• Experience representing Commercial Regulatory Affairs on cross functional teams is desirable.
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Excellent communication skills both in writing and verbally.

Knowledge, Skills and Abilities:

• Experience with FDA’s Office of Prescription Drug Promotion (OPDP) submissions and strategies.
• In-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is required.
• Knowledge of and experience with laws and regulations regarding marketing pharmaceuticals in rest of world (ROW) is highly desired.
• Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
• Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
• Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to influence others.
• Ability to engage multiple stakeholders to achieve the business objective.
• Organized with systematic approach to prioritization.
• Process oriented to achieve the business objective.

Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in a work environment is critical.
• Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands of a global company.

The salary range for this position is $205,000 to $225,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.