ACC is committed to compliance with all applicable equal employment laws. ACC In-house Jobline listings may not explicitly or implicitly discriminate on the basis of any prohibited factor.
Listings on the ACC In-house Jobline are for in-house attorney positions only. While we do not accept non-attorney corporate job listings, if you are hiring a corporate legal operations professional, contact LawDepartmentOps@ACC.com. By posting a job on the ACC In-house Jobline or using the service as a job seeker, you are agreeing to comply with our Terms and Conditions, including those relating to discrimination. The system administrator may delete postings, which do not comply. Employer postings removed by ACC are not subject to refund.
We are very interested in your thoughts as we continue to develop the ACC In-House Jobline to better serve your needs. If you have questions about ACC In-house Jobline, please call our helpdesk at: 1-888-491-8833 Ext. 1125 (Extension Required).
Note you must apply at www.ebsi.com/careers citing Job Reference 17661
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
About this Role
The Senior Regulatory Counsel is an experienced attorney focused in the area of pharmaceutical, biologic, and medical device FDA regulatory and compliance issues. The Senior Regulatory Counsel will provide strategic advice and leadership in the areas governing product labeling, promotion, and distribution issues.
The Senior Regulatory Counsel will work closely with Regulatory, Clinical and Medical Affairs, Marketing, and Commercial Operations, others within the Legal Department and senior management and lead or assist, in all areas of the company’s regulatory compliance, including review of promotional materials, product labeling and regulatory submissions, distribution plans and strategies, and related commercial distribution and sales contracts. The Senior Regulatory Counsel will also lead or assist in regulatory matters involving cross-border transactions and sales, including in the drafting, negotiation, and closing of sales transactions.
Advise on and assist in the review of promotional materials, product labeling, and regulatory submissions
Lead and assist, with a focus on regulatory compliance, on the company’s product marketing plans and strategies
Lead and assist in the drafting, negotiation, and closing of dealer and distribution agreements, for product sales in the U.S. and Internationally
Provide strategic legal advice on the regulatory pathway for obtaining marketing approvals of pharmaceutical, biologic and medical device products
Lead and assist in the drafting and negotiation of other contracts, such as research agreements, license agreements, clinical trial agreements, and manufacturing agreements.
Provide legal advice on operational contracts as required and in particular on those related to areas of responsibility.
Education, Experience and Skills
J.D. and bar membership and minimum of 5 years of relevant legal experience required
Substantial legal experience with a FDA regulatory focus
Substantial legal experience with advertising and promotion laws in the US and internationally
Biopharmaceutical industry experience desired, whether through in-house experience or law firm client base
Experience with International sales and cross-border transactions desired
Experience with contract drafting and negotiation desired
A self-starter and team player who works collaboratively with colleagues across the organization:
By developing relationships with co-workers with a different perspective and supporting peers as applicable
By leading teams on specific matters to achieve specific initiatives By being a trusted advisor
With an awareness of external perceptions of strengths and weaknesses
By using strong presentation skills to senior management
An attorney with an honest appreciation of his or her own capabilities:
Who has excellent analysis and decision-making skills in areas of expertise
Facilitates decision-making with a solutions-oriented mindset
With substantial legal knowledge and experience in primary disciplines
Who produces work product of a high standard with limited supervision
Emergent BioSolutions is a global life sciences company focused on providing specialty products for civilian and military populations that address accidental, intentional and naturally emerging public health threats. As an NYSE-listed company since 2006, Emergent has over a decade of experience operating under NYSE and SEC public-company reporting requirements.