Regulatory Affairs Consultant

7-10 years

Preffered by Company

Bangalore

10 Aug. 26, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Us at Parexel – Where Shared Values Drive Unmatched Achievements

At Parexel, our collective goal is to enhance global health. Every solution we provide, from clinical trials to regulatory affairs, consulting, and market access, is driven by a profound commitment to our mission.

Each team member at Parexel plays a crucial role in developing therapies that positively impact patients. We approach our work with empathy, dedication, and a personal commitment to making a difference.

Position: Regulatory Affairs Consultant

Key Responsibilities:

Regulatory Management:
- Manage pre- and post-approval life cycle management for drug products, including small molecules and biologics, across various markets.
- Develop and implement regulatory strategies and plans for maintenance submissions from both global and regional perspectives.
- Author and review submissions for biologics, biosimilars, and vaccines, including IND & IMPD for USFDA and EMA.
- Prepare and submit BLA/MAA dossiers for US, EU, ROW, and India markets, with a focus on biosimilars.
- Conduct regulatory gap analyses and develop strategy documents with remediation plans for submissions such as IND, IMPD, DMF, CTA, BMF, BLA, NDA, and MAA.
- Oversee life cycle management for approved products, including annual reports, variations, and renewals for Europe.
- Evaluate change controls and deviations, and define regulatory strategies.
- Prepare and submit scientific advice, briefing books, and Type 2 meeting packages for USFDA and EMA.
- Coordinate with internal and external stakeholders to ensure timely and accurate documentation for filings.
- Maintain up-to-date knowledge of regulatory guidelines and assess their impact on submissions.
- Utilize Regulatory Information Management Systems like Veeva Vault effectively.
- Mentor and guide team members, and work independently as needed.
PAREXEL-Related Activities:
- Meet established metrics as specified in the annual scorecard.
- Complete core job responsibilities, including timesheets, expense reports, CV maintenance, training compliance, and project deliverable archiving.
- Participate in internal initiatives and projects as requested by management.
- Engage in self-development activities to remain current in the industry, including maintaining relevant memberships.

Skills:

Proficient in project management and client-focused work.
Results-oriented with strong teamwork and collaboration abilities.
Excellent interpersonal and intercultural communication skills, both written and verbal.
Demonstrated critical thinking and problem-solving skills.
Proficiency in the local language and extensive working knowledge of English.

If you are passionate about regulatory affairs and making a difference in the healthcare industry, we encourage you to apply. Join us in our mission to advance global health through our shared values and commitment.

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Regulatory Affairs Consultant

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