Manager, Regulatory Affairs

1 month ago

Schaumburg, United States Sagent Pharmaceuticals Full time
Job DescriptionJob Description

Sagent Pharmaceuticals – Hyderabad, India

Manager, Regulatory Affairs - Labeling

Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources.

This role is primarily responsible for independently managing the development of labeling and managing key labeling systems and processes to support labeling development and approval at all stages of the product lifecycle at Schaumburg, Illinois and Hyderabad, India. The role will sit in Hyderabad, India.

Success in the role is measured on:

  • Independently ensuring all project timelines and regulatory commitments are met for labeling at all stages of the product lifecycle, and with no disruptions to commercial availability of marketed products, driving measurable efficiencies and continuous improvements in labeling processes.
  • No reworks, delays in launch or commercial availability or quality/regulatory impacts (recalls, etc.)
  • Ability to understand and interpret regulatory requirements and translate this understanding into solid decision making.
  • Ability to work within a flexible framework to meet all regulatory requirements from a design and content point of view in addition to meeting CMO and business requirements wherever possible.

This position is a Subject Matter Expert and does not have any Direct Reports.

This position reports to the Director, RA Labeling.

Any additional responsibilities as assigned by Regulatory or Quality Management.

Key Duties & Responsibilities:

  • 60% - Independently review and approve submission, launch and/or post approval commercial labeling in accordance with NDA/ANDA project goals, FDA requests and responses or commercial/business needs. This includes USPI, Primary, Secondary and Tertiary labeling. Ensure timely execution of shifting labeling priorities to balance all objectives and ensure all project timelines are met by interfacing with CMO’s and internal stakeholders. Review and approve, and at times proofread, all levels of labeling to ensure accuracy of regulatory and GMP requirements. Provide project support and manage labeling development process, including all design aspects.
  • 20% - Develop, maintain and manage quality systems used in support of label development processes, including Label Master Index, Change Controls, File Management, NDC assignment and assessment, and SPL creation for drug listing, submissions, establishment registration and GDUFA. Daily work also includes knowledge of package engineering functions such as reviewing dyelines, barcode creation and maintenance, shipper labels, etc.
  • 10% - Manage indirect labeling staff and hold members accountable for their responsibilities. Develop and guide indirect team members by assisting them in applying new skills, techniques and understandings.
  • 10% - Develop and implement process improvements in label development and label maintenance to ensure continued operating efficiencies. Create/revise SOPs, work instructions, and guides accordingly.

Knowledge or Experience:

  • Understanding of the labeling lifecycle and direct pharmaceutical labeling experience.
  • Understand context and content of label development.
  • Proficiency in proofreading and impeccable attention to detail.
  • Solid command of cGMP, FDA guidelines, and CFR labeling regulations/requirements required.
  • Knowledge of patent/exclusivity carve-outs.
  • Extensive experience in the use of PC- and Mac-based programs including Microsoft Office Word, Excel, Access, Adobe Acrobat Professional and Illustrator. Experience in document comparison software a plus.
  • Previous use of working in TrackWise and SharePoint desired.
  • Previous working knowledge of graphic design and the printing industry desired.
  • Knowledge of SPL creation and Drug Listing/Establishment registration submissions, labeler code requests, regulations and guidance’s a plus.
  • Solid understanding of DSCSA/HDMA regulations.

Key Leadership Competencies:

  • Builds strong relationships with peers and cross-functional colleagues outside of the core team in order to enable higher performance.
  • Learns quickly in order to grasp onto the issues at hand and can change course when needed.
  • Handles risk and ambiguity comfortably; ability to make high-quality decisions with less than perfect information.
  • Ability to manage conflict and difficult conversations across all levels of employees in a constructive and transparent manner.
  • Raises the bar and is never satisfied with status quo.
  • Responsible for the overall well-being of the team/personnel. Encourages managers to develop subordinates. Encourages individual growth and development of employees by providing proper attention to personnel succession planning. Provide regular feedback to team members, in addition to completing annual performance reviews. Builds and maintains employee morale and motivation; fosters a diverse and inclusive workplace.

Minimum Qualifications / Experience:

  • 5 or more years of direct pharmaceutical labeling experience or regulatory submission. The experience must have included decision making experience.
  • Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects.
  • Ability to prioritize projects independently / Experience working on project teams and leading teams.
  • Ability to drive projects to completion with minimal oversight.
  • Solid interpersonal communication skills (written and verbal) at all levels.
  • Supervisory experience.
  • Flexibility and strong negotiation skills.
  • Thrive in, and be able to work in, a fast-paced entrepreneurial environment with broad responsibilities.
  • Possess a broad career progression including experience in multiple departments in pharmaceutical, drug development or manufacturing industry.
  • Have a passion for quality and an impeccable detail orientation.

Education / Certifications:

  • Bachelor’s degree required. Science background degree preferred (Biological, Chemistry, Pharmacy, Pre-Med, Nursing). Will also consider English, Journalism, Business, or Graphic Design degree.

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

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