Sr Manager, Regulatory Affairs

Location
Gaithersburg, MD, US
Posted
Sep 18, 2020
Ref
669239900
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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 Sr. Manager will lead regulatory as the process owner across Emergent Business Units for all product label content considerations. The Sr. Manager for global labeling is responsible for managing the product label content process at Emergent and supporting the Regulatory Product Leads and Project Teams in the development of company core datasheets (CCDSs), clinical and commercial labeling globally. He/she will provide regulatory strategy, direction, support and advice to the team. The Sr. Manager will lead the development of best practices which support the Emergent procedures pertaining to CCDS and label creation for Emergent's products and business areas. The Sr. Manager will be the system owner for the electronic repository of CCDSs and prescribing information and will ensure compliance with health authority requirements and efficient and effective processes. 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.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Lead all regulatory as the global process owner for product labeling activities for Emergent products.
  • Proactively build and manage relationships with external vendors and consultants to support label creation, translations, and general label support.
  • Act as system and process owner for the label content process.
  • Develop and provide training to SMEs involved in labeling creation.
  • Direct and 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.
  • Provide training to other functions on Health Authority requirements for label content as required.
  • Monitor corporate activities for regulatory compliance with respect to labeling.
  • Support the RA leads with critical regulatory review of label content.
  • Mentor and coach junior staff involved in the process.
  • 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) and dynamic product labeling (DPL) considerations and other label content submission concerns.
  • 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.
  • Present to Sr Management and drive decisions on complex material.
  • 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.

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.
• 8-10 years of industry experience in Regulatory Affairs.
• Must have previous experience interacting with FDA and other global regulatory agencies.
• Must have experience with labeling materials; product development and/or post licensure experience within Regulatory Affairs.
• Experience with having previously managed a team of individuals is an asset. RAC certification would also be a plus.

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.