Regulatory Affairs Head
- Pregna International
- 15 - 20 years
- Daman & Diu
- 2 months ago
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Job Description
Key Responsibilities:
- Develop and implement global regulatory strategies to ensure product approvals.
- Market access across multiple regions (FDA, EMA, MHRA, TGA, and Health Canada).
- CMC expert in handling the Initial Submissions and Life cycle management activities for the Global Regulatory for US, Europe, Canada, Australia, China and Emerging Markets for OSDs, Ophthalmic, Complex Injectable and Liposomal Dosage forms.
- Author high-quality CMC documentation (Dossiers and Deficiencies responses) applying agreed CMC regulatory strategies, assuring technical congruency and regulatory
compliance.
- Led cross-functional teams for new product development, regulatory submissions, and
post-approval activities.
- Ensure compliance with international regulatory standards and manage audits and
inspections by global Health authorities.
- Provide regulatory intelligence and strategic advice to senior management on evolving
regulations and their business impact.
- Collaborate with R&D, Quality, and Marketing teams to align regulatory activities with
overall business goals.
- Compilation and submission of Controlled correspondence, Pre-submission meeting
requests, and scientific advice for the US, Canada, and EU markets.
- Evaluation of pre-PIF and provide the regulatory submission requirements for all the US & EU extended approved for AUS, Canada, and EU markets.
- Set regulatory strategies for implementing changes worldwide to ensure business
continuity and a successful Day 1 product launch in Europe, Canada, Australia, the UK, and China (Type IA/IB/Type II supplements, Category 3 notifications).
- Manage a Member regulatory affairs team, ensuring compliance with applicable regulations and standards for pharmaceuticals and biologics, including ANDA, NDA, DCP,CP and ANDS applications.
- Regulatory evaluation of change controls and various other quality events (e.g. Deviations,OOS/OOT etc.) for possible regulatory impact.
- Comprehensive knowledge of Regulatory Software -LIMS, Track-wise, Pharma redy Amplexor etc.
Role & responsibilities
Preferred candidate profile
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Legal & Regulatory - OtherRole: Legal & Regulatory - OtherEmployement Type: Full timeContact Details:
Company: Pregna InternationalLocation(s): Daman & Diu
Keyskills: Regulatory Operations International Projects International Regulatory Affairs Regulatory Compliance Auditing Regulatory Submissions
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Pregna International
ABOUT COMPANYPregna is a leading Contraceptive Solutions Organization and has been serving women since 1991. Pregna is spread across the globe in 140 countries, partnering with social marketing organizations and private distributors in Intrauterine devices.Pregna is the worl...
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