Senior Manager-Regulatory Affairs-EU/US

Ddreg Pharma

15 - 20 years

11 - 12 Lacs

gurugram

Posted:1 day ago| Platform:

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Skills Required

remediation compliance pharma pharmacy cmc manager regulatory affairs gap analysis document management assistant manager regulatory affairs technical documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles Responsibilities

Lead
CMC review of technical documentation
for regulatory filings in
US and EU markets
, including
Gap Analysis and Remediation for Module 3 (CMC)
.
Develop and implement
regulatory strategies, processes, and timelines
for
new product registrations, variations, renewals, and post-approval changes
in the US and EU.
Oversee the preparation, review, and submission of
CTD dossiers
, ensuring conformance with
FDA, EMA, and ICH guidelines
.
Critically evaluate submission documentation for
scientific accuracy, compliance, and internal consistency
.
Provide
regulatory intelligence
by tracking changes in US and EU regulations, guidelines, and best practices.
Collaborate closely with
cross-functional teams (RD, QA, Manufacturing, and Commercial)
to ensure regulatory strategies are aligned with business objectives.
Represent the company in discussions with
regulatory authorities (FDA, EMA, and other relevant agencies)
.
- Mentor and guide junior regulatory team members, fostering a culture of regulatory excellence.

Education Experience

Master s degree in Pharmacy (Pharma)
or a related field.
15+ years of regulatory affairs experience
, with significant exposure to
US and EU CMC submissions
.

Knowledge, Skills Abilities

In-depth knowledge of
US FDA, EMA, and ICH CMC guidelines
.
Strong ability to interpret and analyze complex technical and scientific data.
Exceptional
oral and written communication skills
, with strong presentation abilities.
Proven leadership and mentoring skills with a
collaborative, results-driven style
.
Excellent problem-solving and decision-making capabilities.
Proficiency with
document management systems
and
Microsoft Office Suite
(Word, PowerPoint, Excel, Outlook).
Ability to manage multiple priorities and deliver high-quality outputs under pressure.

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