Am- Regulatory Affairs-international

8 hours ago

Mumbai Maharashtra, India Domnic Lewis Pvt. Ltd Full time

**AM- Regulatory Affairs-International**:
**Domnic Lewis has been Mandated to hire for AM- Regulatory Affairs-International**

**Function / Department**: Regulatory Affairs - International Markets
**Direct Reports**: None

**Primary Purpose of the Role**:
To ensure the timely preparation, review, and submission of high-quality regulatory dossiers for international markets (ROW and Emerging Markets), while maintaining compliance with global regulatory requirements and facilitating successful product registrations and life cycle management.

**Key Responsibilities**:

- Prepare and review CTD and ACTD dossiers for regulatory submissions.
- Coordinate with Manufacturing and R&D teams to collect required data and documents.
- Liaise with manufacturing sites to ensure ongoing regulatory compliance.
- Ensure timely execution of monthly regulatory submission plans and respond to regulatory queries within deadlines.
- Conduct gap analyses and update master regulatory data accordingly.
- Review key regulatory documents including Change Controls, Stability Protocols, Clinical Trial Protocols, and Packaging Artworks.
- Obtain country-specific feedback for variations and ensure timely submissions.
- Handle dossier renewals and update master data records.
- Conduct regular follow-ups with manufacturing teams for documentation and hold periodic review meetings.
- Track and review requirements for upcoming regulatory filings across international markets.

**Required Knowledge, Skills & Experience**:
**Education**:
M.Pharm / M.Sc. (Biotechnology or related discipline)

**Experience**:
6-8 years in Regulatory Affairs with experience in international market submissions

**Technical Skills**:

- Strong knowledge of CTD, ACTD, and eCTD formats
- Familiarity with ICH guidelines and validation requirements
- Experience with regulatory filings for USFDA, EMA, WHO PQ, MCC (South Africa)
- Exposure to in-licensing and out-licensing activities
- Understanding of lifecycle management for biological and biotech products

**Behavioral Competencies**:

- **Planning & Organization**: Ability to manage timelines and coordinate multiple projects
- **Analytical Thinking**: Strong problem-solving and data interpretation skills
- **Communication**: Clear and concise written and verbal communication
- **Team Leadership & People Management**: Ability to lead cross-functional coordination
- **Collaboration**: Works effectively in a team-based environment

  • Regulatory Affairs

    8 hours ago

    Mumbai, Maharashtra, India Actide International Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Job Description:works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.They must have excellent organizational, analytical, project management, and communication skills.They work frequently with other employees and team members to coordinate complex activities, often with...

  • Regulatory Affairs Executive

    2 days ago

    Mumbai, Maharashtra, India R. Wadiwala Sec Pvt Ltd Full time

    Designation : Regulatory Affairs Specialist - Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry - Experience : Minimum 2-5 years of experience in regulatory affairs - Salary : Good Hike on Current CTC - Location : Sandhurst Road Mumbai - Head

  • Regulatory Affairs Interns

    2 days ago

    Mumbai, Maharashtra, India Wellbeing Nutrition Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    About the Role:We are looking for a passionate and detail-orientedRegulatory Affairs Internto support our Regulatory team at Wellbeing Nutrition. This role offers a great opportunity to gain hands-on experience inNutraceutical and Nutrition regulatory processes.Key Responsibilities:Assist in ensuring all FSSAI licenses (NLPL, APOB) are up to dateSupport in...

  • Regulatory Affairs Officer

    8 hours ago

    Mumbai, Maharashtra, India MEDVARSITY ONLINE LIMITED Full time

    Job Title: Senior Executive - Regulatory Affairs UK/IE/MT Department: Regulatory Affairs Grade Level: P-2 Reports to: Manager / Sr. Manager - Regulatory Affairs Number of Reports: NONE Location: Mumbai **Main purpose of role**: To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio...

  • Regulatory Affairs Associate

    4 days ago

    Goregaon, Mumbai, Maharashtra, India Zivira Labs Private Limited Full time

    _**Regulatory Affairs Associate**_ As regulatory affairs associate you'll be the crucial link between the company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed or manufactured, meet the required legislation. **Products include**: - Pharmaceuticals -...

  • Regulatory Affairs Executive

    6 days ago

    Deccan Gymkhana, Pune, Maharashtra, India Zetta Women Full time

    **Job Title**:Pharmaceutical Regulatory Affairs Executive **(Intern)** **Location**: Pune, India **Duration**: 9 months (Advanced Certification) + 3 months (On the Job Internship) **Job Summary**: **Key Responsibilities**: 1. Attend classes on weekends (Saturdays and Sundays) 2. Complete coursework, assignments, and projects 3. Participate in...

  • Regulatory Affairs Officer

    6 days ago

    Mumbai, India Agile Consultants Full time

    **Job Code**:047/001/753 **Location**:Mumbai **Salary**:Based on experience **Industry**:Chemical Manufacturing Our client is hiring an experienced Regulatory Affairs Officer who can provide guidance and support sites with the implementation of Raw Materials such as Lubricant Additives, Epoxy Paints & Coatings, Rubber/Carbon Black, Coating, Foam, and...

  • Regulatory Affairs Specialist

    4 weeks ago

    Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full time

    Job Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...

  • Regulatory Affairs Executive(Female)

    6 days ago

    Mumbai, Maharashtra, India Double HR Consultancy Full time

    VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in...

  • Regulatory Affairs Executive

    1 week ago

    Masjid, Mumbai, Maharashtra, India Amico Formulations LLP Full time

    **Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...