CAREERS

ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

1. Life cycle management and regulatory filing maintenance activities;
• Preparation, review and submission of supplements to existing approvals (with guidance from Senior Regulatory Specialist/ Regulatory Manager).
  
• Monitoring the progress of regulatory submissions, responding to queries and ensuring that approvals are granted without undue delays.
  
• Preparation, review and submission of Annual Reports for ANDAs/NDAs. This also includes the review of documents, utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements.
• Assess and review documentation to ensure compliance with product licences.
• Recommend the appropriate regulatory reporting mechanism using FDA regulations, guidance documents and in-house policies and procedures upon review of Change Control Documentation. Track and monitor change controls using Trackwise Change Control system.
2. New Product Submission Activities;
• Preparation of registration submissions, in CTD format, for approval by the US FDA, European Regulatory Authorities and worldwide, as required (with guidance from Senior Regulatory Specialist/Regulatory Manager).
• Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
3. Establish and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory and site goals.
4. Actively participate in project teams, as required.
5. Make updates to departmental procedures to foster an environment of continuous improvement.
6. Perform other duties as assigned.

QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE
Must possess;
Good knowledge of the USP, 21 CFR and various FDA Guidance’s for Industry.
Knowledge of cGMP awareness and compliance.
Knowledge of sterile products and their regulatory requirements.

SKILLS AND ABILITIES
Excellent communication skills, both oral and written.
Experience in writing and submitting regulatory documentation.
Technical background.
Strong organizational skills.
Accuracy and attention to detail.
Strong work ethic.
Ability to respond quickly to a changing regulatory environment.
Computer skills, E-mail (Lotus Notes), Microsoft Word, Excel, Powerpoint an advantage.

SUPERVISION
Position functions with supervision.

EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) in a science related discipline and 1-2 years’ regulatory experience in the pharmaceutical industry.
However, a combination of experience and/or education will be taken into consideration.


LICENSES/CERTIFICATIONS
Topra certification or RAC, preferred.

LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts.

MATHEMATICAL SKILLS
Ability to read, understand and interpret mathematical technical data.

REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.