Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Advertising & Promotion Oncology Global Regulatory Affairs in our Cambridge, Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Advertising & Promotion working on the Global Regulatory Affairs Oncology team, you will provide regulatory strategic oversight for 2+ therapeutic areas or one highly complex therapeutic area with multiple products to ensure regulatory compliance of promotional materials generated for assigned compounds for the US and Globally as needed. A typical day will include:
- Understands and interprets complex scientific issues as it relates to regulatory requirements and promotional strategy. Responsible for all regulatory aspects of multi-disciplinary or multi-faceted marketing programs
- Able to mentor and develop staff. Supervises trains and provides technical and regulatory guidance to staff.
- Represents the company at regulatory meetings.
- Interacts with all levels of staff at the FDA Office of Prescription Drug Promotion (OPDP). Acts as the lead regulatory representative at OPDP meetings. Provides strategic direction for OPDP meeting preparations. Negotiates regulatory issues with OPDP.
- Interacts with International Agencies regarding promotional issues as needed
- Collaborate with MRL Team and execute and approve major Global /US campaigns. Manage and inform moderate risk.
- Manage submissions including major launch campaigns. Plans, executes and manages regulatory OPDP submissions for assigned compounds. Delegation to staff as appropriate.
- Review and oversee responses to enforcement actions.
- Understands broad concepts within regulatory affairs and implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies
- Executes regulatory activities and provides regulatory support on projects in accordance with applicable regulations and guidelines. Ensures regulatory compliance of promotional materials generated for assigned compounds.
- Provides product development strategy and label development strategy as needed to ensure claims can be supported.
- Evaluates regulatory risks and makes recommendations relative to the overall MRL strategy.
- Manages others regulatory professionals as assigned. Able to mentor and develop staff. Identifies and proposes solutions to management for any resource gaps for brand responsibilities.
- Sets direction for the review of competitive materials globally as needed and interactions with FDA to urge enforcement activity as necessary.
- Presents to Senior Mgt. and cross-functional teams.
- Lead for Regulatory Promotion and Advertising Review for licensing opportunities.
- Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- BS/BSc, preferred; BA accepted, PharmD preferred
- > 8 years industry; inclusive of > 6 years regulatory or related experience. Less experience may be acceptable with PharmD degree.
- Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) e.g. Launch Advisory Materials or responses to enforcement letters.
- Prior people management experience not required, but preferred
- Extensive knowledge of applicable FDA regulations.
- Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
- Able to deal with issues of critical importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance
- Understands regulatory, quality and safety systems impacting drug development and marketed product support.
- Functions independently as a decision-maker on regulatory issues.
- Excellent oral and written skills, timeline responsibilities, negotiations skills. Works well with others, especially on a cross-functional team, direct reports and senior leadership.
- U nderstands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed.
- U nderstand FDA regulations relative to advertising and promotion, for health professional and consumer audiences. Experience in managing multiple filings e.g. Launch Advisory Materials or responses to enforcement or proactive complaints to OPDP about competitors.
- Understands the pharmaceutical industry and has experience in evaluating promotion and advertising materials in multiple therapeutic areas.
- Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes of practice and regulations. Has a thorough knowledge of historical enforcement actions and is readily able to use this in negotiation.
- Demonstrated leadership skills. Ability to effectively manage and bring working teams together for common objectives. Models leaders at all levels daily
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately up to 25% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
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Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations
Boston, MA Worker Type
Employee Worker Sub-Type
Regular Time Type