Title: Director, Regulatory Affairs (Advertising & Promotion)
Reports to: Senior Director, Regulatory Affairs
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, strategic thinker for an important role that is responsible for overseeing the regulatory assessment of external communications regarding Sage products; develop and review regulatory strategies for promotional materials for marketed and pipeline products; provide regulatory input to various functional units on promotional labeling for marketed and to-be marketed drugs, and serve as a the lead regulatory affairs representative on the oversight committees for our lead compound.
Roles and Responsibilities
- Provide regulatory oversight of advertising and promotional activities for the Company’s lead compound
- Develop and implement strategies for achieving effective and compliant communications for commercially available products and investigational products.
- Work collaboratively with cross-functional teams (stakeholders include Marketing, Medical Affairs, Legal, Compliance, R&D) from concept through approval, use and sunset to develop and review materials which are compliant with applicable regulations, guidelines, corporate policies and product development objectives.
- Work collaboratively with cross-functional teams (Medical Science, Medical Affairs, Clinical Operations, Legal, etc) to ensure scientific and medical external communications are non-promotional and compliant with applicable regulations, guidelines corporate polices and product development objectives.
- Oversee the compilation and submission of materials to Regulatory Authorities (e.g. OPDP) as applicable.
- Correspond with Regulatory Agencies related to external communications for the Company’s products.
- Interact effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met.
- Work collaboratively with Compliance to ensure that approved materials are used within the intended guidelines and duration of use.
- Ensure that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising
- Participate in training of sales and marketing personnel on promotion, marketing, labeling and advertising regulations.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Bachelor’s Degree (B.S.) and a minimum of five to seven years related experience in Regulatory Affairs-Advertising and Promotion; minimum of ten years of biotech/pharmaceutical experience in various applicable roles.
- At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
- At least three (3) years in a team leadership role with highly effective people management skills
- Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities.
- Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.
- Proven ability to prioritize and meet project deadlines.
- Ability to determine essential components of requirements in order to include them in applicable policies and procedures.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
- Excitement about the vision and mission of Sage