We're partnered with a mid-sized commercial pharmaceutical company that contains a robust network of proprietary molecules focused on treating endocrine, metabolic, and neuropsychiatric disorders. With a strong financial backing after growing year over year since inception, they are growth oriented which will offer this attorney ample room for personal and professional growth.
This Pharmaceutical Company is looking to bring on an In-House Regulatory Counsel with a legal background who is comfortable working within the regulatory affairs team. You will report into the VP of Regulatory Affairs, who maintains a legal background as well, and be responsible for shaping legal matters within this team - all with the option to sit completely remote!
The In-House Regulatory Counsel will be responsible for:
- Advising on legal and regulatory issues as they arise in connection with pharmaceutical products, including drug development and FDA regulations
- Providing strategic advice regarding customer and other stakeholder relationships, regulatory matters, contracts and interactions with respect to branded/specialty pharmaceuticals.
- Applying knowledge of regulatory requirements across strategic counseling matters, investigations, and corporate transactions.
- Assisting with the drafting of clinical trial agreements and new drug applications with respect to medical writing requirements.
The In-House Regulatory Counsel should possess the following qualifications:
- 5+ years of experience working in-house or at a firm with a pharma/biotech focus
- Juris Doctor (J.D.)
- Experience drafting clinical trial agreements (CTAs) and new drug applications (NDAs). Other contract drafting experience (e.g. supplier, manufacturing, MTAs, SOWs, etc.) preferred
- Past medical writing experience preferred
