Senior Regulatory Affairs Associate

04 Aug, 2022

Jobs

Senior Regulatory Affairs Associate

Veranova
Devens, MA

Company Description

We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.

Job Description

The incumbent is responsible for the assigned Veranova regulatory submissions and the site regulatory operation activities.

Develops strong relationships with internal stakeholders and functional leads to ensure that all dossiers and associated documentation are compliant with applicable regulatory requirements, internal procedures, and cGMP and that they are submitted on-time.

The incumbent collaborates with management/supervisor and customers to define product regulatory strategies. Creates plans and timelines for the execution of the strategy. Proactively anticipates and communicates any potential risk which may derail the submissions from the plan and proposes/executes risk mitigation strategy.

The incumbent proactively supports the creation and maintenance of procedures and policies, support harmonization of practices within Veranova to ensure that they meet the most-up-to date requirements and that industry best practices are implemented. Proactively supports continuous improvement initiatives for the Regulatory Affairs function, the site, and Veranova.

The incumbent helps disseminating regulatory information, coaching more junior personnel and personnel from other functions.

The incumbent represents the Regulatory Affairs department with customers regulatory agencies.

  • Responsible for the day to day regulatory operation activities at the site including but not limited to changes, review and approval of methods, protocols and reports, and product quality reviews, as applicable.
  • Acts as the regulatory project lead for the assigned projects. This includes, but is not limited to, creating and driving timelines, partnering with other functions to prepare the necessary documentation, authoring the regulatory dossiers and responses to questions from regulatory agencies. Monitors timelines to ensure on-time submissions.
  • Responsible for maintaining the dossiers for the assigned projects up to date throughout the product life-cycle, collaborating with other functions, external vendors, and customers. This includes also preparation and submission of annual updates.
  • Facilitate the review of technical regulatory documentation to ensures that the dossiers are complete, accurate, compliant, and right-the-first time.
  • Collaborate in the preparation, review, and submission of documentation required Veranova customers’ or Veranova’s partners’ drug product submissions.
  • Proactively performs gap assessment for Veranova regulatory submissions, suggesting remediation plans and supporting plan execution. Anticipates and communicates potential risks and proposes/executes risk mitigation strategies.
  • Assists and collaborates with Regulatory Affairs personnel from other Veranova locations as needed.
  • Collaborates with supervisor and management in the preparation of regulatory strategies
  • Proactively supports maintenance of local and global regulatory documentation and databases. Identifies trends and areas of improvement and proactively recommends courses of action.
  • Assures all site quality/regulatory registrations with the applicable Agencies are up-to-date and that GDUFA fees are paid on time.
  • Tracks and monitors regulatory and compliance chronologies to ensure that due dates are met. Provides forward looking submission planning for ongoing and future projects.
  • Collaborates with supervisor on preparation and monitoring of the Regulatory Affairs budget.
  • Monitors the regulatory landscape, disseminates information and assesses the potential impact on new guidance on Veranova products or ways of working.
  • Actively participates Functional and Cross Functional Team meetings and acts as regulatory subject matter expert as needed.
  • Actively supports preparation and maintenance of regulatory SOPs/guidances/policies/ templates, facilitating harmonization of practices within Veranova and continuous improvement.
  • Supports site inspections from Health Agencies and site customer audit, as requested.
  • Operates in accordance with cGMP and data integrity principles and helps maintaining the Regulatory Affairs function in a state of compliance.
  • Requires minimal supervision.
  • Any other duty as required.

Qualifications

  • BS in Life Science of Chemistry or related science with at least 5 years related experience in the pharmaceutical manufacturing industry; or a Master’s degree in Chemistry or related science with at least 2 years related experience. Related experience includes experience in quality assurance, quality control, or regulatory affairs.
  • Degree in Regulatory Affairs
  • Understanding of analytical or process chemistry is preferred
  • Familiarity with process for regulatory submission to FDA for APIs or drug products
  • Familiarity with process for regulatory submission to other regulatory agencies as for example EU, MHRA, Anvisa FDA for APIs or drug products
  • Knowledge of US, Canada, EU GMP, and ICH regulations and guidance
  • Experience working in cross-functional teams for project execution
  • Ability to effectively work in a team setting environment
  • Ability to communicate & collaborate effectively with all departments for project execution
  • Strong oral and written communication skills
  • Ability to Plan, Organize and Monitor project execution
  • Ability to perform gap analyses and design gap mitigation plans
  • Strong attention to details and quality orientation
  • Ability to work at multiple projects and tasks at the same time and to quickly adapt to changes in priorities
  • Familiarity with project management and ability to lead improvement projects across multiple sites
  • Self motivation

Additional Information

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.

All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

Learn more here

Job posted: 2022-08-04