Planet Pharma · 5 hours ago
Director of Regulatory Affairs
Durham, NC
Full-time
Onsite
Director/Executive
10+ years expPlanet Pharma is seeking a Director of Regulatory Affairs to work closely with product development teams to set and achieve company goals. This role is responsible for ensuring efficient regulatory submissions and collaborating on strategic drug development programs while maintaining compliance with FDA regulations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Support regulatory strategies for assigned projects that will result in the on-time submission and approval of new products, indications, and variations and ensure proper maintenance of existing product applications
Support and manage the preparation of all US regulatory submissions on assigned projects, including INDs and NDAs/BLAs
Work with Regulatory Operations to compile and submit all US regulatory submissions, including INDs, NDAs, and other required US regulatory filings as necessary
Manage regulatory timelines ensuring that regulatory strategies are executed within approved timelines and communicating identified risks to the timelines to senior management
Interact with US FDA for the coordination and preparation of meetings and teleconferences and conduct informal interactions with the Agency’s personnel as directed by senior regulatory management
Maintain currency with FDA regulations and guidance, including those pertaining to INDs, NDAs, electronic submission requirements, labeling, and review of promotional materials. Is familiar with analogous Ex-US (e.g. EMA, PMDA, etc) regulations and guidance
Provide support to the project teams for submissions to ex-US regulatory authorities, including MAAs, CTAs, PIPs and other filings as necessary
Responsible for leading activities associated with the development and maintenance of the Company Core Data Sheet (CCDS) for assigned projects and working with Medical and Safety in the development of the Company Core Safety Information (CCSI)
Responsible for leading all activities associated with the development, review, approval and submission of Prescribing Information and Patient Labeling including working with appropriate team and leadership staff to ensure that product labeling is consistent with the overall strategy for the product and consistent with the Company Core Data Sheet
Provide regulatory review of all promotional and medical affairs materials as a member of the Legal, Medical, and Regulatory (LMR) team
Review/revise/draft Standard Operational Procedures as required to assure compliance with FDA Regulations and Guidance Documents
Provide mentoring and oversite of direct reports by clearly communicating job expectations and job responsibilities, monitoring and assisting with work progress as needed, and facilitating growth opportunities to maximize potential
All other duties as assigned
Qualification
Required
Bachelor's degree required (advanced degree MS, PhD, PharmD, MD preferred), preferably in a scientific discipline, with experience in the pharmaceutical industry including at least 10 years in regulatory affairs or an equivalent combination of education and experience
Ability to maintain high ethical standards
Strong decision-making skills
Ability to work as part of a team, both in a leadership role and as a contributing member of the company
Ability to develop and maintain positive working relationships with regulatory authorities
Strong interpersonal skills and effective written and verbal communication and presentation skills
Thorough knowledge of US FDA regulations and guidance regarding product development (IND), NDA/CTD preparation and submission, as well as post-marketing requirements
Computer literate (e.g., MS Word, MS PowerPoint, MS Excel)
Preferred
advanced degree MS, PhD, PharmD, MD preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase