Regulatory Affairs Manager

RESPONSIBILITIES

• Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products
• Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries
• Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s)
• Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements
• Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines
• Provide regulatory assessment in change management
• Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
• Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings
• Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges
• Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, Concur (expenses), and Powerpoint
• Performs other duties as assigned

EXPERIENCE

• Minimum of 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead
• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products
• Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canada
• Comprehensive understanding of the global regulatory environment
• Proactive strategic thinker
• Operationally minded (know how to prepare a high quality technical document or submission using internal systems
• Strong analytical, problem solving, organizational and negotiation skills
• Strong collaborative inter-personal, communication, presentation and meeting leading skills
• Strong ability to work in matrixed environment and across cultural lines
• Strong ability to independently manage and prioritize a multi-project load
• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)

• Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology
• RAC certification a plus

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Detailed understanding of clinical methodologies and ability to provide sound analytical support, you quickly establish credibility as a reliable resource.