- BS degree, advanced scientific degree preferred.
- A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience in drug development.
- Preferred experience in managing filings resulting in first-time approval; or managing programs in closely related development area. Experience preparing and submitting INDs, NDAs, and labeling.
- Advertising and Promotional review experience preferred.
- Relies on extensive experience and judgment to plan and accomplish goals.
- Understands and interprets complex scientific issues across projects and area(s) of responsibility as the issues relate to regulatory requirements and strategy.
- Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Must be strong overall in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Exceptionally strong in the following areas: working well with others including cross-functional teams and communication with leadership.
- Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
- Requires approximately 20 % travel.
What We Provide:
At Aclaris Therapeutics, we are proud to offer if eligible, a highly competitive compensation plan with an excellent benefits package including the following:
- Company Sponsored Insurance: Medical, Dental, Vision, Life Insurance, AD&D Insurance Short-Term Disability and Long-Term Disability
- 3 Weeks Paid Vacation
- 14 Paid Holidays
- 401(k) with a generous match!
- On-site Gym with personal trainer, free for employees!
- Fun environment!
- Free Snacks Daily!
- Pizza Friday – free for employees!
- Catered lunches and other fun events!
- Hands-on management to provide comprehensive training and professional development
- Advancement opportunities
- Modern office in beautiful corporate park with access to parks, shopping and restaurants
640 Lee Road
Wayne PA 19087
Aclaris Therapeutics, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity.