Senior Director Strategy-Oncology job in Paramus
|Employer:|| Glenmark Pharmaceuticals Inc., USA|
|Category:||Research and Development|
|State:||New Jersey (NJ)|
Position Summary :
The Regulatory Affairs Lead will serve as the representative for a variety of innovative projects potentially in oncology, autoimmune diseases, and/or respiratory therapeutic areas. The Regulatory Affairs Lead will facilitate product development and global registration to achieve the desired labeling by developing and executing high quality regulatory strategies and effective FDA/health authority interactions. This position will guide development programs, anticipate changes in the regulatory environment and approval requirements. The individual will serve as a credible, influential, respected corporate spokesperson during interactions with regulators and regulatory agencies in the US and ex-US and will provide mentoring and leadership for team during interactions with health authorities.
The initial focus for development will be for the US marketplace and expansion will occur once that strategy is developed and executed. The responsibilities for expansion outside of the US will be to work as part of the global development team to ensure that the strategic vision is defined, understood and synergies, where possible, are incorporated to meet those needs for other regions.
Key Responsibilities :
- Accountable for the development and implementation of innovative regulatory strategies for the project in accordance with applicable US and EU legislation that maximize the likelihood of rapid development and timely registration
- Serve as the Regulatory Affairs (RA) lead representative on the Product Development Team
- Lead the development, communication and update of the Regulatory Plan and be accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures
- Serve as the regulatory representative for the project with responsibility for organizing, submitting and maintaining IND/BLA/NDA submissions
- Serve as the regulatory representative for ex-US Product Development Team and will be overall responsible for management of global regulatory CTA/MAA submissions for the project with assigned/contract regional regulatory support
- Responsible for interactions with FDA including the conduct of regulatory meetings
- Maintain awareness of developing views/guidance within FDA/EMA on general and specific topics of relevance to the therapeutic area and other development projects as appropriate
- Ensure sound regulatory practices are fully integrated in all preclinical, clinical and technical submissions, and evaluate all documents submitted to the FDA and ex-US health authorities to ensure they are complete, well organized, scientifically accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review.
- Initiate and ensure appropriate responses to agency review issues to ensure expedient and efficient review and approval of submissions while effectively managing issues as they arise.
- Bachelor's degree is required with a Master's degree or higher (PhD, PharmD) preferred plus appropriate level of pharmaceutical industry and regulatory affairs experience.
- 12+ years of regulatory experience in the biotech/pharmaceutical industry including 8 years or more of therapeutic experience in oncology, autoimmune disease, and/or chronic pain.
- Full functional knowledge of US and EU regulatory requirements pertaining to the development and registration of biological drug products
- Experience with IND and NDA/BLA filings is required
- Experience contacting the FDA and organizing FDA meetings is required
- Experience with launching new products, working with FDA advisory committee meetings, or labeling negotiations is a plus
- Proven ability to manage complex projects
- Outstanding written/verbal communication skills, good interpersonal skills and familiarity with common computer software programs