Director, Regulatory Affairs
Are you interested in working amongst the brightest people in the regulatory industry, who pride themselves on having the best ideas, innovative solutions and patient-focused achievements in the biopharma arena.
We are currently recruiting for senior Regulatory Affairs professionals who want to work at the forefront of scientific discovery, bringing life-changing results to patients across the globe.
The role is working for a leading global biopharmaceutical organization with an impressive product portfolio across many therapy areas including oncology Infectious disease, cardiology, endocrinology and Rheumatology.
The role is working across large regulatory teams and implementing strategy to support development of products. We are looking for someone who has experience working with health authority documents and leading engagement plans and mitigation strategies.
Due to COVID-19, this role is currently remote based, with long term office locations on both east and west coasts. We have both contract and permanent job opportunities available, depending on preference.
· The Global Regulatory Strategy consultant has leadership responsibility for developing and implementing the global regulatory strategy to support the development and delivery of drug products to enhance the value of our pharmaceutical products across therapeutic areas.
· Provide regulatory support and guidance to the Regulatory team, development teams, commercial and/or project
· Ensure global regulatory plans support an approach (ie integrated drug/ regulatory and submission plans), including HA engagement plans and mitigation strategies.
· Support the preparation of health authority documents and governance presentations containing precision medicine plans.
· Ensure consistent positions are presented in responses to global health authority (HA) queries.
· Propose innovative approaches to resolve complex regulatory issues and increase speed to patients.
· Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products.
· Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with significant experience in regulatory affairs related development (e.g. > 10 years).
· Understanding of scientific content and complexities and good knowledge of Oncology drug development is desired.
· Experience working with external partners.
· Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
· Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.
· Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
· Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
· Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
· Experience utilizing leadership techniques to drive a team through the stages of team development.
· Prior experience with SRDs, IDEs, and PMAs is highly desired.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.
Job Types: Full-time, Contract
Pay: $120.00 - $150.00 per hour
- NDA: 5 years (Preferred)
- Oncology: 3 years (Preferred)
- IND: 5 years (Preferred)
- Regulatory Affairs: 10 years (Required)
- Temporarily due to COVID-19