Bachelor's or advanced degree in life science, biology, regulatory affairs, or healthcare.
5+ years of regulatory experience in biotech or pharmaceutical sectors.
2+ years of supporting cross-functional project teams.
Strong project management and organizational skills required.
Working knowledge of FDA guidelines and ICH regulations for drugs and biologics.
Intermediate experience with eCTD modules and drug development processes.
Proficient with electronic software platforms, MS Office, and advanced Word formatting.
Responsibilities
Advise clients on FDA regulations and policies relevant to CDER and CBER.
Provide regulatory strategy for FDA meetings and applications.
Serve as the Regulatory Contact for FDA interactions.
Lead regulatory processes for FDA submissions related to product life cycle management.
Manage multidisciplinary teams to ensure project deliverables are met on time and within budget.
Identify critical regulatory issues and collaborate on strategies to mitigate them.
Prepare and assess regulatory documents for compliance with FDA guidelines.
Benefits
Flexible working hours to accommodate work-life balance.
Opportunities for continued education and professional development.
Collaborative work culture with multidisciplinary teams.
Mentoring and training opportunities for career growth.
Full Job Description
Job Description: The Regulatory Affairs Manager is the primary point of contact and responsible for facilitating regulatory oversight and management in all phases of drug development. Managing multidisciplinary teams and client interactions to ensure key regulatory milestones and timelines are met.
Responsibilities:
Advise clients on current FDA regulations, policies, and guidance's applicable to CDER and CBER.
Provide regulatory strategy and guidance on FDA requirements for meetings and applications.
Serve as the US agent or Regulatory Contact on behalf of the Sponsor for FDA interactions.
Lead the regulatory process for FDA Meetings, ODDs, DMFs, INDs and any regulatory submissions for product life cycle management.
Provide leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manage day-to-day operations of project tasks/activities to ensure deliverables are met in a timely manner within budget.
In collaboration with the SMEs, identify critical regulatory issues that may impact the development process and provide strategies to address them.
Provide document formatting, preparation and quality assessment of regulatory documents to ensure compliance with FDA guidelines.
Collaborate in multidisciplinary proposal development and following up with outstanding proposals.
Engagement and managing the use of affiliates, when appropriate.
Sharing regulatory intelligence and experience with regulatory affairs.
Participate in continued education to maintain current regulatory knowledge through active participation in conferences and training.
Provide mentoring and training opportunities for colleagues.
Participate in developing and maintaining internal processes and SOPs.
Provide project coverage for team members, when necessary.
Support business development activities and build client relationships to generate referrals.
Other duties as assigned.
Develop experience in the following areas: General understanding of marketing applications (BLAs, NDAs, ANDAs, Biosimilars).
Requirements:
Bachelor's degree or advanced degree in life science, biology, regulatory affairs or healthcare field.
5+ years of regulatory experience in the biotech, pharmaceutical or drug development industry.
2 or more years of supporting cross-functional project teams.
Strong project management and organizational skills.
Working knowledge of FDA regulatory guidelines and ICH regulations related to drugs and biologics.
Intermediate experience of eCTD modules, regulations, submissions, and the drug development processes.
Experience with multiple electronic software/platforms (such as Vantagepoint, Starting Point templates (or similar regulatory templates), Smartsheet, MS Office suite or other project management programs).
Advanced Word formatting skills required.
Demonstrated ability to handle multiple ongoing projects in various stages of development.
Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners.
Ability to work effectively both independently and in a team environment.
Excellent time management skills with the ability to prioritize responsibilities and multitask.
Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners.
Ability to work effectively both independently and in a team environment.
Excellent time management skills with the ability to prioritize responsibilities and multitask.
