Manager Regulatory Affairs
Preparation and review of various regulatory submissions to the appropriate Regulatory Agency. Regulatory submissions, initiation review of change controls and labeling. Collect and review documentation required for filing and track the activities for timely submission.
Act as Regulatory Affairs team member in projects as well as in program teams. Understand pertinent regulations and evaluate impact on projects/existing products
Implement sound regulatory strategies for assigned products/projects within the team and ensure regulatory compliance. Responsibility for the safety and efficacy part of the dossier for new products as well as life-cycle management of existing products for assigned projects/products in US and other markets, when applicable, preparation and review of original submission and amendments. Review the submission documents for accuracy and adequacy and approach the management immediately for any questions or concerns. Maintain the tracker for FDA submissions/Regulatory database
Update the tracker for submissions as and when the submission is made:
Original/ Amendments/ Supplements
Annual reports
Deficiency responses
Stay updated on the Agency's expectations based on guidance and deficiencies and apply the same logic for future submissions to avoid any similar deficiencies Maintain the tracker for FDA submissions/Regulatory database Update the tracker for submissions as and when the submission is made: Original/ Amendments/ Supplements
Degree in Science with at least 5-10 years of experience in the generic pharmaceutical industry. Understanding of regulations relating to generic pharmaceuticals. Understanding of generic drug approval process and associate regulations Vaco values a diverse workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.
EEO Notice Vaco is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race (including but not limited to traits historically associated with race such as hair texture and hair style), color, sex (includes pregnancy or related conditions), religion or creed, national origin, citizenship, age, disability, status as a veteran, union membership, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, political affiliation, or any other protected characteristics as required by federal, state or local law.
Vaco LLC and its parents, affiliates, and subsidiaries are committed to the full inclusion of all qualified individuals. As part of this commitment, Vaco LLC and its parents, affiliates, and subsidiaries will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact .
Vaco also wants all applicants to know their rights that workplace discrimination is illegal.
By submitting to this position, you agree that you will be giving Vaco the exclusive right to present your as a candidate for the foregoing employment opportunity. You further agree that you have represented information about yourself accurately and have not affirmatively misrepresented your qualifications. You also agree to maintain as confidential, to the fullest extent permitted by law, any information you learn from Vaco about the position and you will limit disclosure of information about the position only to the extent necessary to perform any obligations in furtherance of your application. In exchange, Vaco agrees to exercise reasonable efforts to represent you through all solicitation, job screening and resume dispersal.
Privacy Notice Vaco LLC and its parents, affiliates, and subsidiaries ("we," "our," or "Vaco") respects your privacy and are committed to providing transparent notice of our policies.
California residents may access Vaco's HR Notice at Collection for California Applicants and Employees here.
Virginia residents may access our state specific policies here.
Residents of all other states may access our policies here.
Canadian residents may access our policies in English here and in French here.
Residents of countries governed by GDPR may access our policies here.
Pay Transparency Notice Determining compensation for this role (and others) at Vaco depends upon a wide array of factors including but not limited to:
the individual's skill sets, experience and training;
licensure and certification requirements;
office location and other geographic considerations;
other business and organizational needs.
With that said, as required by local law, Vaco believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure. The individual may also be eligible for discretionary bonuses.
