Director, Regulatory Affairs
Responsible for proactively executing on regulatory affairs activities both within and outside the U.S. including, but primarily in the US: (i) executing regulatory interactions, (ii) providing project regulatory interpretation, strategy and guidance, (iii) coordinating regulatory activities handled by vendors and/or CRO’s, and (iv) anticipating and guarding against regulatory risks facing the Company.
- Partner with health authority project managers and review teams to represent their perspective in the Company.
- Develop regulatory strategy for development and commercial projects.
- Provide regulatory guidance and support to various departments including Clinical Research, Manufacturing, Commercial and Business Development.
- Analyze regulatory history and competitor information to provide regulatory intelligence across relevant therapeutic areas and indications.
- Review promotional and non-promotional materials for marketed products, and lead the Medical-Legal-Regulatory Review process
- Coordinate project regulatory operations services.
- Manages, drafts, and aids in securing internal approval of FDA meeting requests and briefing books.
- Manages labeling documents, including preparing package inserts, as well as aiding in quality control of labeling submissions.
- Responsible for managing the compilation, submission and maintenance of INDs, NDAs, amendments and supplements.
- Support and participate in the Company’s due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.
None; but will manage a network of consultants and vendors.
- 7+ years of regulatory experience in the pharmaceutical or biotechnology industry, preferably in an in-house capacity.
- Experience in working with development project teams in a regulatory leadership role.
- Experience with FDA regulations and their impact across the entire development cycle including promotion of pharmaceutical products and labeling.
- Experience across multiple therapeutic areas is a plus.
- Ability to provide strategic and operational guidance across all levels of the company and external vendors.
- Normally receives no instructions on routine work.
- Receives detailed instruction on new assignments only and determines next steps with guidance.
- Define and review goals and objectives and inform management team of changes in objectives and timelines.
- Must be a self-starter, resourceful and able to participate in a highly collaborative, team-oriented environment.
- Must be able to handle, prioritize and follow through on a high volume of work, including the ability to anticipate and manage changing priorities and timelines.
- Must have a strong commitment to corporate compliance.Must be able to work virtually, both as a member of teams and independently.
- Has the ability to work on complex problems in which analysis of situations requires an in-depth evaluation of various factors.
- Suggests and implements solutions to problems.
- Expected to assist others with problem solving.
- Proposes ideas and presents data within own group.
- Participates in interdisciplinary team meetings.
- Is accessible to others for technical advice.
- Highest personal integrity; committed to ethics and scientific standards
- Ability to influence those over whom there is no immediate supervisory capacity to achieve objectives
- Ability to interface with internal customers and stakeholders, industry contacts, and consultants to accomplish corporate objectives
- Excellent communication skills, both oral and written.
- Must work well with others.
- Actively participates in own team meetings.
- Assists other departments as necessary.
Customary Education and Experience
- B.S. in life sciences or chemistry discipline
- Additional regulatory education and/or certification is a plus.
- Some travel required.
- Physical demands consistent with working in an office and laboratory setting.
- Office and virtualsettings
- Moderate noise level
- Flexible hours.
- May be required to work on off hours and weekends
Learn more here
Job posted: 2020-11-19