The PositionReporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Regulatory Affairs Director - Microbiology and Compliance will be responsible for preparing CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, with a focus on sterile manufacturing, including new marketing applications and supplements. Builds and maintains relationships within the Regulatory Affairs functional areas as well as CMC, product supply and device groups. Manages products and change controls in compliance with regulations and company policies and procedures. Manages assigned projects within assigned resources. Maintain compliance of all internal and external policies and regulations, including a focus on GMP compliance-related activities.
RelationshipsReports to the Senior/Executive Director or VP, Regulatory Affairs.
Essential Functions- Strong background in aseptic processing, fill-finish operations, sterilization processes, cleanroom operations, environmental monitoring, quality systems and equipment and process validation
- Experience with supporting FDA cGMP Inspections
- Provides input into CMC regulatory strategies: define regulatory pathways and milestones for submissions to support development activities leading to successful NDA/BLA approvals
- Align CMC regulatory plans with cross-functional development and manufacturing teams
- Direct negotiations and manage strategic FDA interactions related to CMC and GMP compliance and related activities
- Evaluates proposed manufacturing and quality changes for impact to ongoing and existing filings and provides strategic regulatory guidance for optimal implementation of changes
- Facilitates the development of, reviews and comments on all technically complex CMC documentation for submission to regulatory authorities including documentation for drug substance, drug product and drug/device combinations
- Train global functions within regulatory affairs as well as global functions within CMC, product supply and device groups in US specific CMC and compliance requirements
- Monitor changes and evolution in the regulatory CMC landscape for products and analyse the impact of changing regulations on assigned projects
- Manage, train and mentor regulatory affairs personnel.
Physical Requirements0-10% overnight travel required.
Qualifications- A Science degree required; advanced degree strongly preferred; doctorate preferred
- Industry experience of 12 years, of which at least 7 years spent with CMC responsibilities
- Preparing and executing CMC regulatory development strategies in biologics, experience leading successful NDA/BLA submission required, with CMC microbial control experience related to sterile manufacturing
- Excellent interpersonal, oral and written communication skills including presentation skills
- Demonstrated ability to work in a dynamic environment with a high degree of flexibility
- Demonstrated ability to work in a cross functional team and influence the decisions of a team
- Ability to successfully prioritize competing work streams simultaneously
- Highest ethical standards, integrity, credibility and character
The base compensation range for this position is $225,000 to $285,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
