Senior Regulatory Affairs Manager (NJ)
Senior Manager of Regulatory Affairs
New Jersey, USA
Primary responsibilities of this Role
- Develop, communicate and execute regulatory strategies for complex projects including new products.
- Active role in the generation and intradepartmental review of new submissions, supplements, amendments and annual reports.
- Represent or lead the RA function on assigned cross-functional project teams.
- Monitor applicable regulatory requirements. Establish appropriate communication with the Agency, and relay concise information within RA and other functions, primarily at project level.
- Ensure that labeling is compliant with regulations, and in agreement.
- Develop and document sound regulatory decisions and justifications.
- May review promotional material or SOPs for compliance with local and global regulations.
- Sound understanding of U.S. Drug Regulations.
- Knowledge and working experience with eCTD
- Ability to manage complex projects and timelines in a matrix team environment.
- Background in Injectables.
- Demonstrated interpersonal skills including strong negotiation skills.
- Ability to independently identify compliance risks and escalate when necessary.
- Ability to lead and coach others. Will be responsible to mentor and assist in the development of RA staff.
Include the education and experience that is necessary to perform the job satisfactorily.
BA/BS degree in related scientific discipline with a minimum of 6 years' experience in RA. Injectable dosage form experience is preferred and knowledge of device regulations is a plus.
Applying for the job
There are various ways to apply for this position:
- Apply direct from the website (www.tecgroup.net) by clicking "apply now"
- Contact the consultant directly:
About TEC Group International
We are TEC Group. We are international recruitment specialists. We are the link between highly-specialised industries and the professionals that make them work. Expert consultants, a global network of offices and the latest technology allow us to join the dots in the talent process.
TEC Group International supports the Scientific, Engineering and Energy sectors. We have completed assignments in over 60 countries and support projects all over the world through our subsidiaries and partners.