Manager, Regulatory Affairs - Labeling - Remote
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Manager will support the regulatory labeling process owner across Emergent Business Units for all product label content considerations. The Manager will support the product leads for execution of labeling strategies for Emergent products. This includes but is not limited to, supporting the management of the global product label content process at Emergent and support the Regulatory Product Leads and Project Teams in the development of company core datasheets (CCDSs), clinical and commercial labeling globally. He/she will advise on the regulatory strategy and provide direction to the product labeling teams. The Manager will support the development of best practices which support the Emergent procedures pertaining to CCDS and label creation for Emergent’s products and business areas. The Manager will understand and educate the enterprise on global authority regulatory compliance requirements and advise on efficient and effective processes accordingly. They will interact closely with team members and subject matter experts (SMEs) involved in labeling creation and may organize and/or chair labeling committee meetings.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Support all regulatory leads as the global labeling process lead for product labeling activities for Emergent products.
- Proactively build and manage strong collaborative relationships with key internal, external vendors and consultants to support label creation, translations, and general label support.
- Act as a liaison to the system and process owner for the label content process.
- Contribute to the development of and provide training to SMEs involved in labeling creation.
- Support the RA Product Leads and cross-functional teams to ensure consistency on label creation and content across Emergent products.
- Effectively demonstrates and establishes an environment that focuses on the continuous improvement of internal labeling policies and procedures and develops best practices for the labeling content process at Emergent.
- Understand and provide training to other functions on Health Authority requirements for label content as required.
- Monitor corporate activities for regulatory compliance with respect to labeling.
- Proactively raises labeling concerns, risks and issues that may delay/ impact the submission and presents risk mitigation strategy for labeling.
- Support the RA leads with critical regulatory review of label content.
- Support the preparation of label creation and label change documentation and maintain database accordingly.
- Work closely with the regulatory promotional review and non-promotional review teams to ensure consistency in label sources and availability.
- Work closely with Regulatory Operations on structured product labeling (SPL), structured product monograph (SPM) and dynamic product labeling (DPL) considerations and other label content submission concerns.
- Prepare materials and provides support for audits/inspections if required.
- Ensure that change control processes are followed to maintain accuracy of change during versioning of documents.
- Communicate with regulatory agencies regarding labeling submissions, if needed.
- Monitor applicable current and new regulatory requirements within the labeling and CCDS area(s). Provide regulatory intelligence for project teams.
- Interact with company partners and consultants for various regulatory matters as needed.
- Interact with Business Unit teams, other functional managers, and internal/external customers.
- Participate in Regulatory Department initiatives, such as process improvement projects.
- Other duties as assigned.
- The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s degree in a life sciences or related discipline required; advanced Degree (MS or PhD) preferred.
- 5-8 years of industry experience in Regulatory Affairs.
- Must have experience with labeling materials; product development and/or post licensure experience within Regulatory Affairs.
- RAC certification would also be a plus.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.