Assoc Dir - Promotional Reg. Affairs (Symbicort)

Job Summary PRA Associate Director/Senior Manager is responsible for providing leadership and regulatory expertise to Symbicort brand team to ensure that promotional practices are consistent with regulatory guidelines and law and support marketing and sales objectives.

PRA Associate Director/Senior Manager will consult with the PRA Director and/or Skills Leader during review and approval of critical and challenging marketing and sales objectives (high impact). PRA Asociate Director/Senior Manager works with Brand Director, Regulatory Affairs Director, and other brand team members to incorporate US promotional regulatory strategies into the product strategy and is accountable for ensuring that promotional activities meet this strategy, AZ policies and external regulatory guidelines.

PRA Associate Director/Senior Manager also leads/works on special brand team and/or PRA skill center initiatives.

Major Responsibilities
? Facilitates the development, review, and approval of promotional materials and promotional materials and marketing activities to ensure compliance to regulatory guidelines and law, and consistency with corporate policies.
? Reviews promotional material and activities for regulatory compliance, suggests revisions to ensure compliance, and approves promotional materials independently.
? Leads the promotional material review team meetings, reconciles medical and legal comments, and facilitates resolution of disagreements.
? In collaboration with Promotional Regulatory Affairs Skills Leader (PRASL) and Product Team Regulatory Affairs Director (RAD) develops a US promotional regulatory strategy for brand teams.
? Provides US regulatory input into target claims statements and target product profiles including licensing candidates, ensuring proposed claims are adequately supported by data, and will maximize the commercial potential for the US market
? Assumes responsibility for the content of promotional regulatory submissions for the assigned products
? Resolves promotional related issues for product team ? escalating as necessary
? Prepares background material and FDA submission for all DTC, launch, and new campaigns for preclearance from the FDA.
? Prepares background material for all meetings with DDMAC for product team
? Review, approve and sign-off of on promotional material and 2253 submissions.
? Prepares response to untitled and warning letters, and labeling
? Participates in FDA meeting preparation and attends key FDA meeting (when appropriate) that have commercial implications for product teams.
? Works collaboratively with the product team to ensure that quality and regulatory standards are considered throughout the product development life cycle
? Actively works with public relations and product teams during issues management.
? Integrates with PRA Field Partners with respect to the development, review, and approval of field promotional materials.
? Provides product-specific training to new PRA Field Partners.
? Continually monitors the regulatory environment to maintain expertise in regulatory principles, new issues, competitive products, and implications for AstraZeneca.
? Maintains awareness of competitor activities and proactively monitors the regulatory environment for the assigned product teams. Will draft complaint letters to FDA when deemed appropriate by brand team.
? Provide regulatory support for company booths at conferences and scientific meetings.
? Training and mentor other skill center members
? Leads/works on special projects for brand team and/or skill center

? Participate in creation and continuous improvement of overall ?best practices?, and sharing of experiences with PRA team


Responsibilities

Minimum Requirements
? Degree in pharmacy, pharmacology or other life science, or equivalent experience
? 3+ years experience in drug regulatory affairs or related pharmaceutical field; with at least 3 years of promotional regulatory experience
? Experience in interacting with FDA review division(s) or DDMAC.
? Experience in project management and working in a team-based environment
? Excellent verbal and written communication skills
? Demonstrated proficiency in the following competencies: exemplary compliance ethics, high concern for standards, significant attention to detail, strategic and analytic thinking
? Negotiation and facilitation skills
? Problem solving skills

Preferred Background
? Experience in managing, developing, and mentoring people
? Experience in therapeutic areas of AZ focus
? Experience interacting with FDA Division of Drug Marketing, Advertising and Communications, FDA reviewing divisions and working knowledge of drug development process
? Pharmaceutical marketing/commercial experience

Internal and External Contacts/Customers
? PRA Field Partners
? TA Regulatory leaders, TA leaders, and other members of TALT
? Product Team Regulatory Leaders, Product Directors, Product Managers, Development Managers, Promotions Partners, physicians, and other members of the product team
? FDA-DDMAC
? Industry groups and professional associations
? Global regulatory/MAMs
? Legal
? External Vendors