SK Life Science, Inc. Senior Manager, Regulatory Affairs in Paramus, New Jersey
The Sr Manager, Regulatory Affairs will be responsible for managing key regulatory strategy for development programs in the area of CNS.
The responsibilities include working closely with functional areas, project teams, and corporate partner to support product development. The individual must possess a thorough knowledge of global regulations, and guidances governing drugs in all phases of development.
Prepare/coordinate/file/manage the content of IND/CTAs, annual reports, and information amendments in multiple countries.
Lead the preparation and filing of regulatory applications (IND/CTA, NDA/BLA/MAA).
Lead the preparation of responses to questions from Regulatory Authorities.
Interface with functional areas to identify and obtain information required for regulatory submissions.
Develop and/or review regulatory documents to ensure that all submissions are of high quality.
Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met.
Participate in the development of regulatory strategies and provide strategic input and regulatory advice to the project teams on development programs.
Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks.
Interface with global regulatory authorities, consultants, and corporate partners as needed.
Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.
Provide critical review of documents (SOPs, protocols, and reports), as necessary.
Maintain knowledge of current global rules, regulations, and guidances governing development of drugs and biologics in all phases of development.
- BA/BS degree in life sciences or experience in drug development for drugs and biologics that allows for sufficient knowledge in this area. PharmD highly desired.
Strong scientific background with at least seven (7) years of experience Regulatory Affairs in the biotechnology or pharmaceutical industries or (5) years of experience with an Advanced Degree.
Proven ability to successfully manage major submissions and critical projects to deadlines.
Proven ability to successfully interact with regulatory authorities.
Physical and Mental Requirements:
Using effective verbal communication
Using effective written communication
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Job ID: 2021-1567
Street: 461 From Road