Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Director of Regulatory Affairs leading global regulatory activities for cell therapy programs at BlueRock Therapeutics. Driving regulatory strategy and compliance across development lifecycles.
Responsibilities
- Develop overall regulatory strategy for assigned programs, working closely with the nonclinical and clinical teams, in conjunction with the Regulatory CMC and Device leads
- Provide regulatory leadership as the Global Regulatory Lead to program teams and subteams as the go to point of contact for regulatory strategy on assigned program(s)
- Lead the Regulatory Strategy Subteam(s) in the development of global regulatory plans to support assigned program(s)
- Collaboratively identify regulatory risks to product development and design risk mitigation strategies as aligned with cross-functional SMEs
- Provide regulatory support and contribute to the development and implementation of regulatory strategies to support the approval and commercialization of assigned products in compliance with applicable Health Authority requirements, including the identification of gaps or risks and opportunities to expedite development through innovative pathways
- Collaborate cross-functionally with internal teams and subject matter experts to provide regulatory guidance and support throughout the product lifecycle and to prepare regulatory submissions (eg, meeting requests, briefing documents, IND/CTA filings, marketing applications, designation requests, etc…)
- Lead content development, organization, and coordination of cross functional regulatory submissions (e.g., INDs, CTAs, BLA, etc…)
- Author, coordinate, review, and execute submissions and responses to regulatory authorities related to INDs, CTAs, amendments, Information Requests, within appropriate timelines and in accordance with regulations and guidelines.
- Maintain detailed knowledge of the evolving global regulatory landscape relevant for advanced therapies including accelerated review programs. Assess the impact of new regulations/guidance on internal programs and communicate relevant changes to internal stakeholders
- Contribute to regulatory department initiatives to develop procedures and working practices
Requirements
- Strong knowledge of US and international regulations and ICH guidelines
- BS or MS degree in a scientific discipline or related field is required; MS/PhD preferred
- Minimum of 8 years of experience in Regulatory Affairs, with at least some experience in cell or gene therapy
- Demonstrated experience with regulatory products to treat rare diseases and/or unmet medical needs (eg, orphan products, fast track, RMAT, breakthrough therapies, PRIME)
- Demonstrated experience with INDs/ CTAs and life cycle experience. Some experience in cell or gene therapy required. International regulatory experience a plus
- Experience preparing documents for regulatory filings including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with health authorities
- Experience developing and implementing complex regulatory strategies
- Experience developing briefing documents and interfacing with regulatory agencies
- Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box
- Ability to set priorities, work independently, deliver results in a timely manner and adapt and react to new information or changing priorities
- Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences
- Excellent written and oral communication skills with attention to detail. Highly computer literate (Word, Excel PowerPoint), including formatting documents for regulatory submission
- Ability to travel within US/Canada (and some additional, limited EU travel possible) up to 20% is required
Benefits
- Equal Opportunity Workplace
- Support for differences and diversity
- Disability-related accommodations during recruitment process
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