Rocket Pharmaceuticals
Senior Director, Regulatory Advertising and Promotion (Ad/Promo)
Rocket Pharmaceuticals, Cranbury, New Jersey, United States,
Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary:
Rocket Pharma is seeking a strategic and experienced Senior Director of Regulatory Advertising and Promotion (Ad/Promo) to lead and oversee our regulatory affairs in these crucial areas. This role is integral in ensuring that our advertising and promotional activities are fully compliant with regulatory requirements while supporting our overall business strategy. The ideal candidate will possess a deep understanding of regulatory frameworks, a proven track record in managing complex regulatory projects, and exceptional leadership skills.
Responsibilities:
Regulatory Strategy and Leadership:
Develop and execute regulatory strategies for advertising and promotion, across all therapeutic areas and product lines.
Provide expert guidance to marketing, medical, and commercial teams to ensure compliance with regulatory requirements and alignment with strategic objectives.
Lead and mentor regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement.
Advertising and Promotion Compliance:
Oversee the review and approval of promotional materials, including advertisements, brochures, digital content, social media campaigns, and educational materials, ensuring they meet regulatory standards and company policies.
Develop and implement internal guidelines and processes for the creation, review, and approval of promotional content to ensure consistent regulatory compliance.
Ensure that promotional claims are accurate, substantiated with clinical or scientific evidence, and compliant with FDA, EMA, and other global regulatory guidelines.
Evaluate the effectiveness and regulatory compliance of promotional activities, making adjustments as necessary to address compliance issues or regulatory concerns.
Provide strategic input on the development and execution of promotional strategies and campaigns to ensure they align with regulatory requirements and business objectives.
Address and resolve issues related to regulatory inspections or audits of promotional practices and materials.
Develop and implement streamlined processes and best practices for regulatory submissions and documentation management.
Cross-Functional Collaboration:
Collaborate with cross-functional teams, including legal, medical affairs, and commercial, to ensure cohesive and compliant messaging and documentation.
Facilitate effective communication between regulatory affairs and other departments to support the timely and compliant launch of products.
Risk Management and Problem Resolution:
Identify and assess potential regulatory risks related to advertising, promotion, labelling, and operations, developing strategies to mitigate these risks.
Lead investigations into regulatory issues or compliance breaches, providing actionable solutions and corrective actions as necessary.
External Engagement:
Represent the company in interactions with regulatory agencies, industry groups, and other external stakeholders on advertising, promotion, labelling, and operational matters.
Monitor and influence industry developments and regulatory changes, applying this knowledge to enhance the company's regulatory strategies.
Qualifications:
B.S./B.A required; advanced degree preferred (M.S., Ph.D., PharmD or equivalent) in a relevant scientific discipline.
Minimum of 10 years of experience in regulatory affairs with a strong focus on advertising, promotion, and labelling.
Proven track record of managing complex regulatory projects related to promotional materials and campaigns in a pharmaceutical, biotech, or medical device environment.
Extensive experience in the regulatory review process for diverse promotional materials including print, digital, and social media content.
Demonstrated experience in developing and implementing internal regulatory policies and procedures for promotional content.
In-depth knowledge of regulatory requirements for advertising and promotion in major markets such as FDA, EMA, and other global regulatory bodies.
Proven experience in leading teams and managing cross-functional projects, including interacting with regulatory agencies and handling regulatory inspections or audits.
Expert knowledge of FDA, EMA, and international regulations and guidelines for advertising, promotion, and labelling.
Strong leadership and management skills, with a proven ability to build and lead high-performing teams.
Excellent analytical and problem-solving abilities, with a strategic approach to addressing regulatory challenges.
Exceptional communication and interpersonal skills, with a demonstrated ability to influence and collaborate effectively with internal and external stakeholders.
Ability to manage multiple projects and priorities simultaneously in a fast-paced, dynamic environment.
EEO Statement:
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
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Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary:
Rocket Pharma is seeking a strategic and experienced Senior Director of Regulatory Advertising and Promotion (Ad/Promo) to lead and oversee our regulatory affairs in these crucial areas. This role is integral in ensuring that our advertising and promotional activities are fully compliant with regulatory requirements while supporting our overall business strategy. The ideal candidate will possess a deep understanding of regulatory frameworks, a proven track record in managing complex regulatory projects, and exceptional leadership skills.
Responsibilities:
Regulatory Strategy and Leadership:
Develop and execute regulatory strategies for advertising and promotion, across all therapeutic areas and product lines.
Provide expert guidance to marketing, medical, and commercial teams to ensure compliance with regulatory requirements and alignment with strategic objectives.
Lead and mentor regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement.
Advertising and Promotion Compliance:
Oversee the review and approval of promotional materials, including advertisements, brochures, digital content, social media campaigns, and educational materials, ensuring they meet regulatory standards and company policies.
Develop and implement internal guidelines and processes for the creation, review, and approval of promotional content to ensure consistent regulatory compliance.
Ensure that promotional claims are accurate, substantiated with clinical or scientific evidence, and compliant with FDA, EMA, and other global regulatory guidelines.
Evaluate the effectiveness and regulatory compliance of promotional activities, making adjustments as necessary to address compliance issues or regulatory concerns.
Provide strategic input on the development and execution of promotional strategies and campaigns to ensure they align with regulatory requirements and business objectives.
Address and resolve issues related to regulatory inspections or audits of promotional practices and materials.
Develop and implement streamlined processes and best practices for regulatory submissions and documentation management.
Cross-Functional Collaboration:
Collaborate with cross-functional teams, including legal, medical affairs, and commercial, to ensure cohesive and compliant messaging and documentation.
Facilitate effective communication between regulatory affairs and other departments to support the timely and compliant launch of products.
Risk Management and Problem Resolution:
Identify and assess potential regulatory risks related to advertising, promotion, labelling, and operations, developing strategies to mitigate these risks.
Lead investigations into regulatory issues or compliance breaches, providing actionable solutions and corrective actions as necessary.
External Engagement:
Represent the company in interactions with regulatory agencies, industry groups, and other external stakeholders on advertising, promotion, labelling, and operational matters.
Monitor and influence industry developments and regulatory changes, applying this knowledge to enhance the company's regulatory strategies.
Qualifications:
B.S./B.A required; advanced degree preferred (M.S., Ph.D., PharmD or equivalent) in a relevant scientific discipline.
Minimum of 10 years of experience in regulatory affairs with a strong focus on advertising, promotion, and labelling.
Proven track record of managing complex regulatory projects related to promotional materials and campaigns in a pharmaceutical, biotech, or medical device environment.
Extensive experience in the regulatory review process for diverse promotional materials including print, digital, and social media content.
Demonstrated experience in developing and implementing internal regulatory policies and procedures for promotional content.
In-depth knowledge of regulatory requirements for advertising and promotion in major markets such as FDA, EMA, and other global regulatory bodies.
Proven experience in leading teams and managing cross-functional projects, including interacting with regulatory agencies and handling regulatory inspections or audits.
Expert knowledge of FDA, EMA, and international regulations and guidelines for advertising, promotion, and labelling.
Strong leadership and management skills, with a proven ability to build and lead high-performing teams.
Excellent analytical and problem-solving abilities, with a strategic approach to addressing regulatory challenges.
Exceptional communication and interpersonal skills, with a demonstrated ability to influence and collaborate effectively with internal and external stakeholders.
Ability to manage multiple projects and priorities simultaneously in a fast-paced, dynamic environment.
EEO Statement:
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
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