Specialist - Regulatory Informatics and Operations

American Health Packaging; Hinoba-an; On-site; PHP 300,000 - 600,000; Full time

Job summary

PharmaLex India Private Limited. is seeking a Regulatory Informatics & Operations specialist to support dossier publishing and regulatory submissions for US and EU regions.

You will manage pre-publishing, compilation, and post-publishing activities and contribute to process improvements. The role requires a B.Pharm or science degree with 3+ years of experience, familiarity with US/EU eCTD submissions, and preferred Veeva publishing expertise.

Qualifications

• B.Pharm or other Science degree; M.Pharm preferred.
• Minimum 3 years of experience.
• Experience in regulatory informatics and operations.

Responsibilities

• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• Good understanding and participation in regulatory processes providing high-level Regulatory Informatics & Operations support in dossier Modules 1 to 5 for all applicable document types and Health Authority regions.
• Supporting pre-publishing, dossier compilation, dossier publishing and post-publishing activities.
• Good understanding and working knowledge of US and EU eCTD submissions across all submission types.
• Veeva Tool knowledge is preferred.
• To be able to work in CET/US shift timezone.

Skills

Submission publishing

US Publishing experience

Veeva tool experience

Veeva Publishing experience

Education

B.Pharm or other Science degree

M.Pharm preferred

Tools

Veeva

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

Responsibilities

• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• Good understanding and participation in regulatory processes providing high-level Regulatory Informatics & Operations support in dossier Modules 1 to 5 for all applicable document types and Health Authority regions.
• Supporting pre-publishing, dossier compilation, dossier publishing and post-publishing activities.
• Good understanding and participation in regulatory processes providing high-level Regulatory Informatics & Operations support for informatics related Health Authority initiatives.
• Good understanding and working knowledge of US and EU eCTD submissions across all submission types.
• Veeva Tool knowledge is preferred.
• to be able to work in CET/US shift timezone.

Qualifications and Experience

• B.Pharm or other Science degree, M.Pharm preferred
• Minimum 3 years of experience

Skills & Knowledge

• Submission publishing (mandatory)
• US Publishing experience
• Veeva tool experience (preferred)
• Veeva Publishing experience

Flexibility

Must be open to working in shifts if required.

Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice.
• The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Contract Type

Full time.

Affiliated Companies

PharmaLex India Private Limited.

Equal Employment Opportunity

Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals.

Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.

If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail].

We will make accommodation determinations on a request‑by‑request basis.

Messages and emails regarding anything other than accommodations requests will not be returned.

Company Description

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose‑driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.