Regulatory Operations Principal Specialist

Job Overview:

• Perform various project management and regulatory affairs activities for Fortrea clients.

• Manage team including performance reviews, human resource issues, and assist Senior Management

in assigning resources to projects as required.

• Manage, coordinate and oversee the overall Regulatory Operations associated with

creation/revision/compilation/approval of specifications, regulatory and labeling documents across

the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities

within the agreed/stated timelines, as applicable.

• The post holder is responsible for supporting team members in providing this service to clients either

as a support function to the client project groups or as stand-alone business.

• Provide all clients, both internal and external, with the appropriate quality of service in a safe and

cost-effective manner.

Summary of Responsibilities:

These statements are intended to describe the general nature of the job and are not intended to be an

exhaustive list of all responsibilities, skills, and duties as individual contributor and/or managing 1-20

direct reportees.

• Manage day-to-day operations and delivery for specific Regulatory Operations engagements;

oversee assigned projects, including all aspects of Regulatory Operations

• May manage individuals across multiple teams and will take on responsibility for cross department

projects.

• Assist in project allocation and resourcing.

• General oversight for the receipt and processing of all the requests received. This includes, but is

not limited to, oversight of the following types of tasks:

o Update and maintenance of the project specific tracker as applicable

o Review of various Regulatory Operations documents for their completeness, accuracy and

appropriately within required timelines, as applicable

o Reporting of any criticalities to the clients, and Fortrea. project personnel if required.

• Facilitate co-ordination and support for preparation, compilation & review of product quality

(CMC) & other regulatory documents including labeling to support product development or

submissions to various countries across the world for product registrations or post approval life

cycle maintenance, as applicable

• Support the use and development of tools and processes to support label development and

worldwide submissions and approvals, as applicable

• Participate in process improvement initiatives.

• Work closely with clients to ensure client satisfaction, in transition and delivery and ensure delivery

of services meets or exceeds Service Level Agreements.

• Work closely with the Quality Assurance department at Fortrea to develop SOPs and training

material and provide training as appropriate.

• Assist in training and mentoring of the project team.

• Implement process & productivity improvements as appropriate to improve operational efficiency.

• Prepare and participate in audits, either by the client or a regulatory agency.

• Consistently contributes to solving technical and/or operational problems identified by

program/project members.

• Working with company leadership to define project objectives, processes, policies, procedures and

rules.

• Well versed with product knowledge.

• Participate in cross-functional meetings as needed.

• Responsible for cascading relevant information from internal and external meetings to appropriate

colleagues.

• Assist with the generation, review and implementation of SOPs, Work Instructions etc.

Qualifications (Minimum Required):

• Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or

Masters) with experience of 7-9 years. “Fortrea may consider relevant and equivalent experience in

lieu of educational requirements.” OR

• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 7-

9 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in

Packaging with minimum 7-9 years of experience will be preferred. “Fortrea may consider relevant

and equivalent experience in lieu of educational requirements.”

• Speaking-English and/or other languages as applicable

Experience (Minimum Required):

• At least 1+ year experience in project management and people management is desirable

• Industry experience of which 7-9 years of experience in the job discipline (e.g. Regulatory Affairs /

Quality Assurance / Analytical science / Packaging, polymer and/or printing stream / Formulation

science / Material Management and overall Drug Development and Manufacturing Process.

• Technical proficiency with Microsoft Office suite of applications/ Document Management and/or

publishing tools.

• Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and

ICH-GCP guidelines desirable

• Good organizational and time management ability.

• Good analytical capabilities and Customer focus.

• Good verbal, written and presentation skills.

• Leadership capabilities.

• High degree of accuracy with attention to detail.

• Ensure client and global regulatory compliance.

• Anticipate/identify problems and takes appropriate action to correct.

• Capabilities to face internal and external Audit situation.

Preferred Qualifications Include:

• Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or

Masters) with experience of 7-9 years. “Fortrea may consider relevant and equivalent experience in

lieu of educational requirements.” OR

• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 7-

9 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in

Packaging with minimum 7-9 years of experience will be preferred. “Fortrea may consider relevant

and equivalent experience in lieu of educational requirements.”

• Knowledge of data management system, pharmaceutical product life cycle and Management

Information System (MIS) will be preferred.

• Knowledge of data management system and pharmaceutical product life cycle will be preferred.

• 1+ year experience in project management and people management is desirable.

• Diploma or certification in Regulatory Affairs will be preferred.

Physical Demands / Work Environment:

• Physical demands: Available for regional or global travel 5-10% of the time including overnight

stays as necessary consistent with project needs and office location.

• Work environment: Office

Learn more about our EEO & Accommodations request here.