Pharmaceutical RA Manager Position Description
- This position on the Regulatory team is accountable for the relationship with the US Food and Drug Administration, along with other relevant regulatory bodies. It is responsible for the local execution of Company's regulatory initiatives in line with business goals.
- Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/countries.
- Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
- Represent or lead the RA function on assigned cross-functional project teams
- Monitor applicable regulatory requirements; assure compliance with Company and external standards
- Establish appropriate communication within RA and other functions primarily at project level
- Perform gap analysis and propose solutions
- Develop and document sound regulatory decisions and justifications
- Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
- May provide direct supervision of individuals
- May review promotional material or SOPs for compliance with regulations
- Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects.
- Higher degree/PhD will be an advantage.
- Technical skills: Documentum, SharePoint, Word, Excel, PowerPoint, Outlook (all other programs they will use, they can learn.)
- Experience with US Drug Submissions (NOT MEDICAL DEVICE)
- Previous leadership experience in a similar role.
- Change Control in US Drug Products including assessment, analysis, etc.
- Submission to FDA including prior approval, Changes Being Efficient (CBE)
- Creating annual reports.
- Sound basis of Regulatory knowledge
- Scientific Knowledge
- Ability to manage complex projects and timelines in a matrix team environment
- Strong oral and written communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
- Ability to independently identify compliance risks and escalate when necessary
- Ability to lead and coach others
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.