Specialist - Regulatory Informatics and Operations

PharmaLex; Dadri; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Cencora, via its PharmaLex India Private Limited affiliate, invites applicants to join a team focused on Regulatory Informatics and Operations in dossier modules for US and EU markets. The role emphasizes developing and maintaining client relationships, supporting pre-publishing, dossier publishing, and post-publishing activities, with preference for Veeva tool experience and CET/US shift readiness.

Qualifications include a B.Pharm or other science degree, an M.Pharm is preferred, and a minimum

Qualifications

• Submission publishing and US publishing experience are mandatory.
• Veeva tool experience is preferred, including Veeva Publishing experience.

Responsibilities

• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• Support regulatory informatics & operations in dossier modules 1 to 5 for all applicable document types and Health Authority regions, including pre-publishing, dossier compilation, publishing and post-publishing activities.
• Engage in informatics-related Health Authority initiatives and ensure high-level regulatory informatics & operations support.
• Demonstrate working knowledge of US and EU eCTD submissions across all submission types.
• Work CET/US shift timezone as required.

Skills

Submission publishing

Veeva tool

Education

B.Pharm or science degree

M.Pharm preferred

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.

Qualification

• B.Pharm or other Science degree, M.Pharm preferred

Experience

• 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

What Cencora offers

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.

Full time

Affiliated Companies

Affiliated Companies: PharmaLex India Private Limited

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